Casodex is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Casodex is used to treat prostate cancer that has spread to other parts of the body (metastatic).

Casodex is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

Warnings

Casodex is used to treat prostate cancer. This medicine should never be taken by a woman or a child.

Bicalutamide can harm an unborn baby if you father a child while using this medicine. Use effective birth control to prevent pregnancy while using Casodex and for at least 130 days (about 19 weeks) after your last dose.

Casodex can harm your liver. Call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Before taking this medicine

You should not use Casodex if you are allergic to bicalutamide.

Use effective birth control if your sex partner is able to get pregnant. Bicalutamide can harm an unborn baby if you father a child while using this medicine. Keep using birth control for at least 130 days (about 19 weeks) after your last dose.

Casodex is not for use by women or children.

This medicine can cause birth defects if a woman takes it during pregnancy.

To make sure Casodex is safe for you, tell your doctor if you have:

• liver disease; or
• diabetes.

How should I take Casodex?

Take Casodex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Casodex is usually taken once per day in the morning or evening.

Take the medicine at the same time each day, with or without food.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor’s instructions.

You should not stop using Casodex unless your doctor tells you to.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Prostate Cancer:

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:
-Therapy with this drug should be started at the same time as therapy with an LHRH analog.
-If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Use: For use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Casodex could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Casodex side effects

Get emergency medical help if you have signs of an allergic reaction to Casodex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• liver problems–nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills;
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
• (if you also take warfarin) unusual bruising or bleeding.

Common Casodex side effects may include:

• anemia;
• blood in your urine;
• fever, chills, flu-like symptoms;
• trouble breathing;
• hot flashes;
• pain in your back, pelvis, or stomach;
• swelling in your arms, ankles, legs, or feet;
• increased night-time urination;
• weakness, dizziness; or
• nausea, diarrhea, constipation.

Bicalutamide is a prescription medicine belonging to a class of medicines called non-steroidal androgen receptor inhibitors.

Bicalutamide is used to treat prostate cancer that has spread to other parts of the body (metastatic).

Bicalutamide is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

It is not known if bicalutamide tablets are safe and effective in children.

Warnings

Bicalutamide can harm an unborn baby if you father a child while using this medicine. Use effective birth control to prevent pregnancy while using bicalutamide and for at least 130 days (about 19 weeks) after your last dose.

Before taking this medicine

You should not use this medicine if you are allergic to bicalutamide.

Use effective birth control if your sex partner is able to get pregnant. Bicalutamide can harm an unborn baby if you father a child while using this medicine. Keep using birth control for at least 130 days (about 19 weeks) after your last dose.

Bicalutamide is not for use by women or children.

This medicine can cause birth defects if a woman takes it during pregnancy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease; or
• diabetes.

How should I take bicalutamide?

Take bicalutamide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Bicalutamide is usually taken once per day in the morning or evening.

Take the medicine at the same time each day, with or without food.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor’s instructions.

You should not stop using bicalutamide unless your doctor tells you to.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Prostate Cancer:

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:
-Therapy with this drug should be started at the same time as therapy with an LHRH analog.
-If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Use: For use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking bicalutamide?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Bicalutamide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Bicalutamide side effects

Get emergency medical help if you have signs of an allergic reaction to bicalutamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• liver problems – nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor; or
• (if you also take warfarin) unusual bruising or bleeding.

Common bicalutamide side effects may include:

• anemia;
• blood in your urine;
• fever, chills, flu-like symptoms;
• trouble breathing;
• hot flashes;
• pain in your back, pelvis, or stomach;
• swelling in your arms, ankles, legs, or feet;
• increased night-time urination;
• weakness, dizziness; or
• nausea, diarrhea, constipation.

What is histrelin?

Histrelin overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily.

The Supprelin LA brand of histrelin is used to treat precocious puberty in both male and female children who are at least 2 years old.

The Vantas brand of histrelin is used to treat symptoms of prostate cancer in men. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself.

Histrelin may also be used for purposes not listed in this medication guide.

Histrelin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Histrelin may cause serious side effects. Call your doctor at once if you have:

• bone pain, numbness or weakness in your legs or feet;
• painful or difficult urination, blood in your urine;
• a seizure;
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• mental problems–crying spells, anger, aggression, feeling restless or irritable.

Common side effects of histrelin may include:

• constipation;
• urination problems;
• breast swelling;
• hot flashes;
• feeling tired;
• erectile dysfunction (impotence), decreased testicle size; or
• pain, redness, bruising, swelling, or skin irritation where the implant was inserted.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Histrelin can harm an unborn baby or cause a miscarriage. Do not use if you are pregnant.

Histrelin can cause side effects such as crying spells, anger, aggression, and feeling restless or irritable. Call your doctor if you have any new or worsening mental problems.

Before taking this medicine

You should not be treated with histrelin if you are allergic to histrelin or to similar hormone medications such as leuprolide, nafarelin, ganirelix, Eligard, Lupron, Viadur, and others.

Do not use histrelin if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy and tell your doctor right away if you become pregnant.

Vantas should not be used in women or children.

To make sure Supprelin LA is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• a tumor or blood vessel disorder in your brain; or
• if you take a medicine that can cause seizures (such as an antidepressant).

To make sure Vantas is safe for you, tell your doctor if you have ever had:

• a bladder obstruction or other urination problems;
• diabetes;
• heart problems, heart attack, or stroke;
• long QT syndrome (in you or a family member);
• low bone mineral density (osteoporosis); or
• a condition affecting your spine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Supprelin LA should not be used in a child younger than 2 years old. Vantas is not approved for use by anyone younger than 18 years old.

How is histrelin given?

Histrelin is given in a tiny implant inserted under the skin on the inside of your upper arm. You will receive this implant with a minor surgical procedure in a clinic or doctor’s office.

It is best to place the implant into your non-dominant arm (your left arm if you are right-handed). Be sure to tell your doctor which arm you use most often.

The skin of your upper arm will be treated with a numbing medicine to keep you from feeling pain during the insertion. Your doctor will use a scalpel to cut a small incision where the implant will be inserted.

The histrelin implant is inserted using a special tool that pushes the implant into place through the incision in your skin. After injecting the implant and removing the insertion tool, your doctor will then feel your arm to make sure the implant has been correctly placed.

The incision in your skin may be closed with stitches or surgical strips. Follow your doctor’s instructions about caring for the incision and keeping it bandaged and clean until it heals completely. Keep your arm dry for at least 24 hours.

You will most likely be able to feel the implant through your skin, but it should not cause pain or discomfort.

Call your doctor if you have any pain, swelling, tenderness, itching, tingling, bruising, or redness where the implant was inserted, or if the implant comes through the skin or falls out.

A histrelin implant is usually left in place for 12 months and then must be removed through a surgical incision. Do not try to remove the implant yourself. Your doctor will determine whether you need another implant for continued treatment.

You may have a temporary increase in precocious puberty symptoms for a week or so after you have received the Supprelin LA implant.

You may need medical tests to help your doctor determine how long to treat you with histrelin.

Histrelin can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using histrelin.

Histrelin dosing information

Usual Adult Dose for Prostate Cancer:

VANTAS:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: The implant is designed to allow for a few additional weeks of drug release to allow flexibility of medical appointments); when an implant is removed, another implant may be inserted to continue therapy.

Use: Vantas: Palliative treatment of advanced prostate cancer

Usual Pediatric Dose for Precocious Puberty:

SUPPRELIN LA:
2 years and older:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: When an implant is removed, another implant may be inserted to continue therapy.

Comments:
-Discontinuation of therapy should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).

Use:
Supprelin LA: Treatment of children with central precocious puberty

What happens if I miss a dose?

Since histrelin is given as an implant, it does not have a daily dosing schedule.

The implant should not be left in your arm for longer than 12 months. Call your doctor when it is time for your implant to be removed.

What happens if I overdose?

Since the histrelin implant contains a specific amount of the medicine, you are not likely to receive an overdose.

What should I avoid after receiving a histrelin implant?

For at least 7 days after your implant is inserted, avoid strenuous exercise or heavy lifting.

What other drugs will affect histrelin?

Other drugs may affect histrelin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is letrozole?

Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.

Letrozole may also be used for purposes not listed in this medication guide.

Letrozole side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of letrozole may include:

• hot flashes, warmth or redness in your face or chest;
• headache, dizziness, weakness;
• bone pain, muscle or joint pain;
• swelling, weight gain;
• increased sweating; or
• increased cholesterol in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use letrozole if you are pregnant.

Before taking this medicine

You should not use letrozole if you are allergic to it.

letrozole is for use only in women who can no longer get pregnant. Letrozole can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Keep using birth control for at least 3 weeks after your last dose of letrozole. Tell your doctor if you think you may be pregnant.

Tell your doctor if you have ever had:

• liver disease (especially cirrhosis);
• osteoporosis, osteopenia (low bone mineral density);
• high cholesterol; or
• if you also take tamoxifen.

You should not breastfeed while you are using letrozole and for at least 3 weeks after your last dose.

How should I take letrozole?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take letrozole with or without food.

You will need frequent medical tests, and your bone mineral density may also need to be checked.

Store at room temperature away from moisture and heat.

Letrozole dosing information

Usual Adult Dose for Breast Cancer:

2.5 mg orally once a day

Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy

Usual Adult Dose for Breast Cancer — Adjuvant:

2.5 mg orally once a day

Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What should I avoid while taking letrozole?

Avoid driving or hazardous activity until you know how letrozole will affect you. Your reactions could be impaired.

What is leuprolide?

Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer.

Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age or older to treat central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics).

Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms).

Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus).

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

Leuprolide side effects

Get emergency medical help if you have signs of an allergic reaction to leuprolide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have a seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Leuprolide may cause serious side effects. Call your doctor at once if you have:

• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• a seizure;
• unusual changes in mood or behavior (crying spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination;
• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of muscle use, loss of bladder or bowel control;
• problems with your pituitary gland – sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• high blood sugar – increased thirst, increased urination, hunger, dry mouth, fruity breath odor;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Common leuprolide side effects may include:

• pituitary gland problems;
• acne, itching, rash, white scales (seborrhea);
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fractures, ligament sprain;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• wheezing, chest tightness, trouble breathing;
• breast tenderness, hot flashes, sweating;
• dizziness, sleep problems, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• irregular menstrual periods, decreased interest in sex; or
• redness, pain, swelling, or oozing where the medicine was injected.

Leuprolide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using leuprolide.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Call your doctor at once if you have a seizure, unusual changes in mood or behavior, severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Do not use leuprolide if you are pregnant. Use effective birth control. Do not use if you have abnormal vaginal bleeding that has not been checked by a doctor.

Before taking this medicine

You should not use this medicine if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

To make sure leuprolide is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or psychosis;
• seizures or epilepsy;
• a blood vessel disorder;
• a brain tumor or spinal cord injury;
• heart disease, congestive heart failure, long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Call your doctor if your periods continue while you are being treated with leuprolide.

Leuprolide may cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use leuprolide?

Uae leuprolide as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

There are many brands, strengths, or forms of leuprolide used to treat different conditions. Avoid medication errors by using only the medicine your doctor prescribes.

Leuprolide is usually administered by a healthcare provider.

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider may teach you how to properly use the medication by yourself.

Your symptoms may become temporarily worse as your hormones adjust to leuprolide. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

You may need frequent medical tests while using leuprolide.

Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with leuprolide. Your pharmacist can provide more information about how to store this medicine.

Dosing Information

Usual Adult Dose for Endometriosis:

3.75 mg IM once a month for up to 6 months
OR
11.25 mg depot every 3 months

Comments:
-In women receiving this drug for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms.

Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Usual Adult Dose for Prostate Cancer:

Eligard: administered by subcutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

• One 7.5 mg injection every month; or
• One 22.5 mg injection every 3 months; or
• One 30 mg injection every 4 months; or
• One 45 mg injection every 6 months,

Viadur: one implant inserted for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal therapy.

Usual Pediatric Dose for Precocious Puberty:

IM Injection:
2 years and older:
One month depot injection: 25 kg or less: 7.5 mg IM once a month. Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month. Greater than 37.5 kg: 15 mg IM once a month
Three month depot injection: 11.25 mg or 30 mg IM every 3 months

Comments:
-Doses should be titrated to the individual.
-Hormone levels should be tested after 1 to 2 months of therapy and with each dose change to ensure adequate pituitary gonadotropin suppression.
-Once a dose that results in adequate hormonal suppression has been determined, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy.
-Therapy should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.

Subcutaneous injection:
2 years and older:
Fensolvi (long acting formulation): 45 mg subcutaneously every 6 months
NOTE: The short-acting formulation has been replaced with long-acting formulations.

Comments:
-The dosage should be adjusted for weight changes.
-Discontinuation of therapy be considered before age 11 for females and before age 12 for males.

Use: Treatment of children with central precocious puberty (CPP); CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; it may show a significantly advanced bone age that can result in diminished adult height

What is Lupron Depot?

Lupron Depot is a long-acting, prescription hormonal injection used to treat various hormone-related conditions, such as advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty (CPP) in children (Lupron Depot-Ped only).

• Lupron Depot and Lupron Depot-Ped are given by injection every 1, 3, 4, or 6 months depending on the condition.
• Lupron Depot-Ped is only for CPP. 
• “Depot” refers to the delivery system. The medication is suspended in microspheres that slowly break down over 1-6 months.

Lupron Depot (leuprolide acetate) first gained FDA approval on April 9, 1985. There is no generic.

FDA approvals and indications

Lupron Depot is approved for advanced prostate cancer, endometriosis, and uterine fibroids.

Advanced prostate cancer

The treatment of advanced prostate cancer.

Endometriosis

The management of endometriosis, including pain relief and reduction of endometriotic lesions.

• May be used alone or in combination with norethindrone acetate (add-back therapy) to reduce bone loss and hot flashes associated with Lupron depot use. 
• The total duration of treatment should not exceed 12 months.

Uterine Fibroids

To improve anemia due to vaginal bleeding from uterine fibroids (uterine leiomyomata) in combination with iron therapy in patients in whom 3 months of hormonal suppression is deemed necessary.

• The duration of treatment is limited to 3 months.
• The symptoms associated with fibroids will return after stopping therapy.

Healthcare providers may consider a 1-month trial of iron alone, as some women will respond to iron alone.

• Lupron Depot may be added if the response to iron alone is inadequate.

Central Precocious Puberty

Lupron Depot-Ped is approved to treat children aged at least 1 year with central precocious puberty (CPP).

Side effects

Prostate Cancer

The most common side effects of Lupron Depot are:

• general pain and joint problems
• hot flashes or body sweats
• gastrointestinal disturbances
• swelling and fluid build-up (edema)
• respiratory problems
• urinary problems
• injection site reactions, such as redness, swelling, or pain at the injection site
• shrinking of the testes
• weakness, lack of energy, or fatigue
• skin reactions.

Endometriosis or Uterine Fibroids

The most common side effects of Lupron Depot are:

• hot flashes or body sweats
• headache or migraine
• vaginal inflammation with vaginal itching, discharge, or pain
• depression or mood swings
• general pain
• weight gain/loss
• nausea or vomiting
• decreased sex drive
• dizziness.

Central Precocious Puberty

The most common side effects of Lupron Depot-Ped are:

• injection site reactions such as pain, swelling, and abscess
• weight gain
• pain throughout body
• headache
• acne or red, itchy, rash, and white scales (seborrhea)
• serious skin rash (erythema multiforme)
• mood changes
• swelling of the vagina (vaginitis), vaginal bleeding, and vaginal discharge.

When Lupron Depot-Ped is administered once every 6 months, other common side effects include upper stomach pain, bleeding, diarrhea, nausea and vomiting, fever, itching, pain, rash, ligament sprain, fracture, breast tenderness, difficulty sleeping, chest pain, and excessive sweating.

Serious side effects and warnings

Your symptoms may become temporarily worse during the first 2 to 4 weeks of treatment when you first start using Lupron Depot. In adults with prostate cancer, increases in serum testosterone of more than 50% above baseline may cause a tumor flare. Tell your healthcare provider immediately if you develop increased bone pain, nerve pain, blood in your urine, difficulty urinating, or spinal pain.

In adults or children prescribed Lupron Depot for other conditions this may cause transient worsening of symptoms, including the signs and symptoms of endometriosis or uterine fibroids during the first few weeks of treatment. In children, there may be a temporary increase in the clinical signs and symptoms of puberty, including vaginal bleeding. Tell your doctor if any increase in symptoms continues for longer than 2 months.

Cardiovascular disease. There is an increased risk of serious cardiovascular problems, including heart attacks, sudden cardiac death, and strokes in men receiving Lupron Depot. Your doctor will monitor your heart health more closely while you’re on this medication. Tell your healthcare provider immediately if you experience chest pain or pressure, shortness of breath, or sudden weakness or numbness, especially on one side of the body.

May be associated with an increased risk of seizures. The risk of seizures may be higher in people who have a history of seizures, have a history of epilepsy, have a history of brain or brain vessel (cerebrovascular) problems or tumors, are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs). Seizures have also happened in people without any of these problems. Call your healthcare provider right away if you, your child, or the person you are caring for has a seizure while taking Lupron Depot or Lupron Depot-Ped.

May increase the risk of psychiatric events or mood changes, such as emotional lability (eg, crying, irritability, impatience, anger, and aggression). Call your healthcare provider at once if you, your child, or someone you are caring for has unusual changes in mood or behavior. 

Increased pressure in the fluid around the brain (Pseudotumor Cerebri) can happen in people receiving GnRH agonist medicines such as Lupron Depot or Lupron Depot-Ped. Call your healthcare provider right away if you, your child, or the person you are caring for has any of the following symptoms during treatment:

• headache
• eye problems, including blurred vision, double vision, or decreased eyesight
• eye pain
• ringing in the ears
• dizziness
• nausea.

There is an increased risk of developing diabetes in people receiving GnRH agonists such as Lupron Depot. Your doctor will monitor your blood glucose level and manage any changes according to guidelines.

Lupron Depot can harm an unborn baby or cause birth defects. Do not use it if you are pregnant or breastfeeding.

Lupron Depot or Lupron Depot-Ped may cause an allergic reaction. Get emergency medical help if you develop signs of an allergic reaction such as hives, sweating, fast heartbeats, dizziness, difficulty breathing, swelling in your face or throat, or a severe skin reaction which may include a red or purple skin rash that spreads and causes blistering and peeling.

Also, call your healthcare provider at once if you have:

• A sudden severe headache
• A wheezing, dry cough, or hack
• Bone pain
• Heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• High blood sugar, symptoms may include increased thirst, increased urination, hunger, dry mouth, or fruity breath odor
• Loss of movement in any part of your body
• Muscle weakness or loss of use, loss of bowel or bladder control
• Pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet
• Painful or difficult urination
• Problems with your eyes or vision
• Rapid weight gain
• Signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech
• Sudden chest pain or discomfort
• Swelling
• Unusual changes in mood or behavior (crying spells, anger, feeling irritable)
• Vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How does Lupron Depot work?

Lupron Depot (leuprolide acetate) works by suppressing the body’s production of certain hormones through a process called “chemical castration” or “medical castration.” This creates a temporary state of low sex hormones, which can be beneficial for treating conditions that are stimulated or worsened by these hormones.

Mechanism of Action: Lupron is a gonadotropin-releasing hormone (GnRH) agonist. When first administered, it briefly stimulates the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

Down-regulation: With continuous use, Lupron causes desensitization and down-regulation of GnRH receptors in the pituitary gland. This leads to a dramatic decrease in the production of LH and FSH.

Hormone Suppression: The reduction in LH and FSH leads to significantly decreased production of sex hormones (testosterone in men, estrogen in women).

• In men: Testosterone levels drop significantly
• In women: Estrogen levels decrease substantially.

Before taking this medicine

Do not use Lupron Depot or Lupron Depot-Ped if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, or nafarelin; Lupron Depot, Lupron Depot-Ped, any of the inactive ingredients in the injection, or if you have abnormal vaginal bleeding that a doctor has not checked.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

To make sure Lupron Depot is safe for you, tell your healthcare provider about all your medical conditions including if you have ever had:

• depression, mental illness, or psychosis
• seizures or epilepsy
• a blood vessel disorder
• a brain tumor or spinal cord injury
• heart disease, congestive heart failure, long QT syndrome
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood) or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Call your doctor if your periods continue while you are being treated with this medicine.

Do not give this medicine to any child without medical advice.

Pregnancy and Breastfeeding

Lupron Depot usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Leuprolide can cause birth defects and should not be used if you are pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy because leuprolide can make hormonal birth control less effective. Tell your doctor right away if you inadvertently become pregnant.

You should not breastfeed while using leuprolide.

Leuprolide may cause infertility, although research shows full reversibility of fertility suppression when leuprolide is discontinued after continuous administration for up to 24 weeks. Lupron may be used to delay egg release for IVF treatment.

How is Lupron administered?

Initially, Lupron Depot must be administered under the supervision of a healthcare provider, although some people can be taught how to self-administer it themselves.

• Lupron Depot is given into a muscle.
• The dosing schedule varies depending on the condition being treated but it may be every 1, 3, 4, or 6 months.

Different brands or strengths of leuprolide are used to treat different conditions.

• Always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

You may need frequent medical tests while using this medicine.

Keep all scheduled visits to the doctor. If a scheduled dose is missed, the person receiving Lupron Depot or Lupron Depote-Ped may start having symptoms or signs of puberty again.

• Your healthcare provider will do regular exams and blood tests.

Lupron Depot Dosage

Lupron Depot dosage for advanced prostate cancer:

Lupron Depot dosage for endometriosis

Lupron Depot 3.75 mg administered as a single intramuscular (IM) injection once every month for up
to six injections (6 months of therapy).

• May be administered alone or in combination with daily norethindrone acetate 5 mg (add-back treatment)
• If endometriosis symptoms recur after the initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone acetate add-back therapy. Do not re-treat with Lupron Depot 3.75 mg alone. 

Lupron Depot dosage for uterine fibroids

• Lupron Depot 3.75 mg is administered as a single intramuscular (IM) injection once every month for up to three injections (3 months of therapy).

Lupron Depot-Ped dosage for central precocious puberty (CPP)

The dosage of Lupron Depot-Ped must be individualized for each child. Dosage recommendations are based on body weight.

• Adjust dosages as body weight changes.
• The dosage may be increased if adequate hormonal and clinical suppression is not achieved.
• Your healthcare provider will monitor your child’s response to Lupron Depot-Ped.

Dosage Lupron Depot-Ped for 1-month administration

• Administer Lupron Depot-Ped 7.5 mg, 11.25 mg, or 15 mg for 1-month administration as a single-dose intramuscular injection once every month.

Dosage Lupron Depot-Ped for 3-month administration

• Administer Lupron Depot-Ped 11.25 mg or 30 mg for 3-month administration as a single-dose intramuscular injection once every 3 months (12 weeks).

Dosage Lupron Depot-Ped for 6-month administration

• Administer Lupron Depot-Ped 45 mg for 6-month administration as a single-dose intramuscular injection once every 6 months (24 weeks).

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What should I avoid while using Lupron Depot?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Lupron Depot?

Leuprolide can cause serious heart problems. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Store Lupron Depot and Lupron Depot-Ped in the original carton at room temperature, away from moisture and heat. Protect from light.

Keep out of reach of children.

Ingredients

Lupron Depot ingredients

Lupron Depot 3.75 mg for 1-month administration

Active ingredients: leuprolide acetate 3.75 mg
Inactive Ingredients: acetic acid, water for injection, polysorbate 80, mannitol, purified gelatin, 
carboxymethylcellulose sodium, 

Lupron Depot 7.5mg for 1-month administration

Active ingredients: leuprolide acetate 7.5 mg

Inactive ingredients: purified gelatin, DL-lactic and glycolic acids copolymer, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, glacial acetic acid, USP to control pH.

Lupron Depot 22.5 mg for 3-month administration

Active ingredients: leuprolide acetate 22.5 mg

Inactive ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot 30 mg for 4-month administration

Active ingredients: leuprolide acetate 30 mg

Inactive ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot 45 mg for 6-month administration

Active ingredients: leuprolide acetate 45 mg

Inactive ingredients: polylactic acid, D-mannitol, stearic acid, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot-Ped ingredients

Lupron Depot-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: purified gelatin, DL-lactic and glycolic acids copolymer, D-mannitol,
carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to
control pH.

Lupron Depot-Ped 11.25 mg or 30 mg for 3-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water
for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot-Ped 45 mg for 6-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, and stearic acid, carboxymethylcellulose sodium, Dmannitol, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH. 

Who makes Lupron Depot and Lupron Depot-Ped?

AbbVie Inc. makes Lupron Depot and Lupron Depot-Ped. AbbVie is headquartered in North Chicago, Illinois, USA. It was formed in 2013 when it split off from Abbott Laboratories as an independent biopharmaceutical company.

What is medroxyprogesterone?

Medroxyprogesterone tablets are used to treat abnormal menstrual bleeding, absent or irregular menstrual periods (amenorrhea) and to prevent thickening of the lining of the uterus (endometrial hyperplasia) in postmenopausal women who are taking estrogen hormone replacement therapy. Medroxyprogesterone is a progestin hormone.

Warnings

You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

Before taking this medicine

You should not use this medicine if you are allergic to medroxyprogesterone, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;
• liver disease;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Medroxyprogesterone may cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

To make sure medroxyprogesterone is safe for you, tell your doctor if you have:

• heart problems;
• liver problems;
• asthma;
• migraine headaches;
• a thyroid disorder;
• endometriosis (severe pelvic pain);
• jaundice caused by pregnancy or birth control pills;
• kidney disease;
• high or low blood levels of calcium;
• a seizure;
• diabetes; or
• lupus.

Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Do not breastfeed.

How should I take medroxyprogesterone?

Take medroxyprogesterone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Medroxyprogesterone is usually given for only a few days in a row each month.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using this medicine.

If you need major surgery or will be on long-term bed rest, you may need to stop using medroxyprogesterone for a short time. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using medroxyprogesterone.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Endometrial Hyperplasia — Prophylaxis:

Oral tablets:
5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16 th day of the cycle

Comments:
-Postmenopausal woman with a uterus taking estrogens should also initiate progestin therapy to reduce the risk of endometrial cancer.
-Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. Starting dose should be the lowest.
-Periodically re-evaluation (e.g., 3 to 6 month intervals) to determine if treatment is still necessary is recommended.
-In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Use: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets

Usual Adult Dose for Abnormal Uterine Bleeding:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days, beginning on the 16 th or 21 st day of the menstrual cycle

-Dose to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: 10 mg daily for 10 days beginning on the 16 th day of the cycle

Comments:
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with the oral tablets.
-Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with the oral tablets.

Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Usual Adult Dose for Amenorrhea:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days

Dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen:
-10 mg daily for 10 day

Comments:
-Therapy may be started at any time.
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug.

Use: Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking medroxyprogesterone?

Avoid smoking while you are taking medroxyprogesterone. Smoking greatly increases your risk of blood clots.

Medroxyprogesterone side effects

Get emergency medical help if you have signs of an allergic reaction to medroxyprogesterone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding;
• confusion, memory problems;
• a breast lump; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common medroxyprogesterone side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• headache, dizziness, feeling nervous or depressed;
• breast tenderness or discharge;
• stomach discomfort, bloating, nausea, vomiting;
• itching, rash, acne, hair growth, hair loss;
• premenstrual type symptoms (bloating, fluid retention, mood changes);
• weight gain;
• bruising or swelling of your veins;
• tiredness, trouble sleeping; or
• vision changes and difficulty wearing contact lenses.

What is Nilandron?

Nilandron is used to treat prostate cancer that has spread to other parts of the body.

Nilandron is for use in men who have undergone surgical castration.

Nilandron may also be used for purposes not listed in this medication guide.

Nilandron side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nilandron may cause serious side effects. Call your doctor at once if you have:

• chest pain, wheezing, dry cough, fever;
• new or worsening shortness of breath;
• flu symptoms, pale skin, feeling tired; or
• liver problems–nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Nilandron may include:

• hot flashes;
• dizziness;
• constipation;
• nausea or vomiting, loss of appetite;
• skin rash;
• decreased libido, impotence; or
• vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects .

Warnings

You should not use Nilandron if you have severe liver disease or severe breathing problems.

Nilandron can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath.

Before taking this medicine

You should not use Nilandron if you are allergic to it, or if you have:

• severe liver disease; or
• severe breathing problems.

Tell your doctor if you have ever had:

• liver disease; or
• asthma or another lung disease.

Nilandron is not for use in women, and the effects of Nilandron during pregnancy or in breastfeeding women are unknown.

How should I take Nilandron?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Treatment with Nilandron should be started on the day of or on the day after surgical castration.

You may take Nilandron with or without food.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Nilandron?

Nilandron may cause a delay in your ability to see in the dark after you have been in a lighted area. Be careful when driving at night, when entering a tunnel, and in similar situations. Wearing tinted glasses may help lessen this effect.

Drinking alcohol with Nilandron may cause dizziness, flushing (warmth, redness, or tingly feeling), or other unpleasant symptoms.

What is nilutamide?

Nilutamide is used to treat prostate cancer that has spread to other parts of the body.

Nilutamide is for use in men who have undergone surgical castration.

Nilutamide may also be used for purposes not listed in this medication guide.

Nilutamide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nilutamide may cause serious side effects. Call your doctor at once if you have:

• chest pain, wheezing, dry cough, fever;
• new or worsening shortness of breath;
• flu symptoms, pale skin, feeling tired; or
• liver problems–nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of nilutamide may include:

• hot flashes;
• dizziness;
• constipation;
• nausea or vomiting, loss of appetite;
• skin rash;
• decreased libido, impotence; or
• vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use nilutamide if you have severe liver disease or severe breathing problems.

Nilutamide can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath.

Before taking this medicine

You should not use nilutamide if you are allergic to it, or if you have:

• severe liver disease; or
• severe breathing problems.

Tell your doctor if you have ever had:

• liver disease; or
• asthma or another lung disease.

Nilutamide is not for use in women, and the effects of nilutamide during pregnancy or in breastfeeding women are unknown.

How should I take nilutamide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Treatment with nilutamide should be started on the day of or on the day after surgical castration.

You may take nilutamide with or without food.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from moisture and heat.

Nilutamide dosing information

Usual Adult Dose for Prostate Cancer:

-Initial dose: 300 mg orally once a day for first 30 days

-Maintenance dose: 150 mg orally once a day after first 30 days

-Comments: For maximum benefit, treatment should begin on the same day or the day after surgical castration.

Use: Treatment of metastatic prostate cancer (Stage D2) in combination with surgical castration.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking nilutamide?

Nilutamide may cause a delay in your ability to see in the dark after you have been in a lighted area. Be careful when driving at night, when entering a tunnel, and in similar situations. Wearing tinted glasses may help lessen this effect.

Drinking alcohol with nilutamide may cause dizziness, flushing (warmth, redness, or tingly feeling), or other unpleasant symptoms.

What is Nubeqa?

Nubeqa is a prescription androgen receptor inhibitor used to treat prostate cancer.

Nubeqa is used to treat prostate cancer that has not spread to other parts of your body and no longer responds to a medical or surgical treatment that lowers testosterone (non-metastatic castration-resistant prostate cancer or nmCRPC).

Nubeqa is also used to treat prostate cancer that has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (metastatic castration-sensitive prostate cancer or mCSPC). It can be used alone or in combination with docetaxel. 

It is not known if Nubeqa is safe and effective in children or in females.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

To make sure Nubeqa is safe for you, tell your doctor if you have ever had:

• liver or kidney disease.

Darolutamide may harm an unborn baby or cause a miscarriage. Nubeqa is not for use by women. Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while you are using Nubeqa.

It may be harder for you to get a woman pregnant while you are using Nubeqa. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Nubeqa is not for use by women or by anyone younger than 18 years old.

How should I take Nubeqa?

Take Nubeqa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take with food.

Swallow the tablet whole and do not crush, chew, or break it.

If you have not had castration surgery (to lower the amount of testosterone in your body), your doctor may also prescribe a gonadotropin-releasing hormone (GnRH) medicine such as Eligard, Lupron, Trelstar, Zoladex, or Vantas. Keep using your GnRH as directed.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing information

Usual Adult Dose for Prostate Cancer:

• 600 mg (2 x 300 mg tablets) orally 2 times a day.
• Swallow tablets whole.
• Take with food.
  
  Comments:
  – Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
  – For patients with mCSPC treated with Nubeqa in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of Nubeqa treatment.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Nubeqa side effects

Get emergency medical help if you have signs of an allergic reaction to Nubeqa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe ongoing nausea or diarrhea;
• painful or difficult urination;
• blood in your urine;
• severe headache, blurred vision, pounding in your neck or ears;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a lung infection – fever, chills, cough with mucus, chest pain, shortness of breath.

Your cancer treatments may be delayed if you have certain side effects.

Common Nubeqa side effects may include:

• feeling tired;
• pain in your arms, hands, legs, or feet;
• rash;
• low white blood cells; or
• abnormal liver function tests.

When used in combination with docetaxel in mCSPC, the most common side effects of Nubeqa are:

• constipation
• rash
• decreased appetite
• hemorrhage
• increased weight
• high blood pressure
• laboratory test abnormalities, such as anemia, high blood glucose levels, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and low calcium levels. 

What is raloxifene?

Raloxifene is used to treat osteoporosis in postmenopausal women.

Raloxifene is not for use in men.

Raloxifene may also be used for purposes not listed in this medication guide.

Raloxifene side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Raloxifene may cause serious side effects. Stop using raloxifene and call your doctor at once if you have:

• swelling, tenderness, or other changes in your breasts;
• signs of a stroke–sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;
• signs of a blood clot in the lung–chest pain, trouble breathing, coughing up blood; or
• signs of a blood clot deep in the body–swelling, warmth, or redness in an arm or leg.

Common side effects of raloxifene may include:

• hot flashes;
• leg cramps;
• swelling in your hands, feet, or ankles;
• joint pain;
• flu symptoms; or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

raloxifene may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

Raloxifene can also increase your risk of a stroke, which can be fatal. This risk is highest if you have certain risk factors (such as smoking, having heart problems or high blood pressure, or if you have ever had a heart attack or a stroke).

Although this medicine is for use only in postmenopausal women, you should not take raloxifene if you are pregnant or breastfeeding.

Before taking this medicine

This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.

This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.

Do not breastfeed while taking raloxifene.

Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:

• heart problems, irregular heartbeats;
• a heart attack or stroke, including “mini-stroke”;
• high blood pressure;
• cancer; or
• if you smoke.

Tell your doctor if you have ever had:

• a blood clot;
• high triglycerides caused by using estrogen;
• liver or kidney disease;
• endometriosis;
• abnormal vaginal bleeding; or
• if you have not gone through menopause.

How should I take raloxifene?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

If you need major surgery or will be on long-term bed rest, you will need to stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take raloxifene.

Raloxifene is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor’s instructions very closely.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

Store at room temperature away from moisture and heat.

Raloxifene dosing information

Usual Adult Dose for Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Osteoporosis:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

Usual Adult Dose for Prevention of Breast Cancer:

60 mg orally per day

Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.

Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking raloxifene?

If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

What is Aromasin?

Aromasin ) lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Aromasin is used to treat early and advanced breast cancer in postmenopausal women. Early breast cancer is cancer that has not spread outside the breast. Advanced breast cancer is cancer that has spread to other parts of the body.

Aromasin is sometimes given after you have taken tamoxifen for 2 or 3 years, or if tamoxifen did not work or has stopped working.

Warnings

You should not use Aromasin if you are allergic to exemestane, if you have not started menopause, or if you are pregnant or able to become pregnant.

Do not use Aromasin if you are pregnant. It could harm the unborn baby.

Before using this medicine, tell your doctor if you have liver or kidney disease, or if you have not yet completed menopause and are still having menstrual periods.

Use Aromasin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep taking take this medicine for up to 5 years. Follow your doctor’s instructions. This medicine may not work as well if you take it together with hormone replacement medication.

Before taking this medicine

You should not use Aromasin if you are allergic to exemestane, or if:

• you are pregnant or able to become pregnant; or
• you have not yet completed menopause, and are still having menstrual periods.

Some drugs should not be used together with Aromasin. Your doctor may change your treatment plan if you also use medicines that contain estrogen, such as:

• birth control pills, patches, injections, or implants; or
• hormone replacement therapy.

To make sure Aromasin is safe for you, tell your doctor if you have ever had:

• liver or kidney disease; or
• if you are still having menstrual periods.

Exemestane can decrease bone mineral density, which may increase your risk of developing osteoporosis. Talk to your doctor about your individual risk of bone loss.

This medicine is for use only in women who can no longer get pregnant. Exemestane can harm an unborn baby. Do not take this medicine if you are pregnant or may become pregnant. You may need to have a negative pregnancy test before starting this treatment.

If you are not past menopause, use effective birth control to prevent pregnancy while you are taking Aromasin and for at least 1 month after your last dose. Tell your doctor right away if you become pregnant.

This medicine may affect fertility (your ability to have children). However, if you are not past menopause you should still use birth control to prevent pregnancy because exemestane can harm an unborn baby.

You should not breastfeed while using this medicine and for 1 month after your last dose.

How should I take Aromasin?

Take Aromasin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Aromasin is usually taken once per day, after a meal. Try to take the medicine at the same time each day.

You will need frequent medical tests.

Your doctor may have you take extra vitamin D while you are taking Aromasin. Take only the amount of vitamin D that your doctor has prescribed.

Use Aromasin regularly to get the most benefit. You may need to keep taking take this medication for up to 5 years.

Store in the original container at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Breast Cancer:

25 mg orally once a day

Comment:
-This drug should be administered after a meal.

Uses:
-Adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy.
-Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Aromasin side effects

Get emergency medical help if you have signs of an allergic reaction to Aromasin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain or pressure;
• new or unusual bone pain;
• swelling in your hands or feet;
• feeling short of breath, even with mild exertion; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Aromasin side effects may include:

• hot flashes;
• headache, feeling tired;
• joint pain;
• nausea;
• increased appetite;
• sleep problems (insomnia); or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Aromasin?

When you start or stop taking Aromasin, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs may interact with exemestane, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 

What is Arimidex?

Arimidex lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Arimidex is used to treat breast cancer in postmenopausal women.

Arimidex is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox).

Warnings

Arimidex may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.

Do not use anastrozole if you are pregnant. It could harm the unborn baby.

Arimidex may not work as well if you take it together with estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings).

Arimidex may increase your risk of a stroke or blood clot. Call your doctor at once if you have sudden numbness or weakness, (especially on one side of the body), sudden severe headache, slurred speech, or problems with vision or balance.

Before taking this medicine

You should not use Arimidex if you are allergic to anastrozole, or if you have not yet completed menopause.

Arimidex is not approved for use in men or children.

You should not take anastrozole if you also take tamoxifen.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems;
• coronary artery disease (clogged artery disease);
• high cholesterol; or
• osteoporosis or low bone mineral density.

Hormonal cancer treatment can weaken your bones. You may be more likely to have a broken bone while using Arimidex. Talk with your doctor about ways to keep your bones healthy.

Although it is not likely that a postmenopausal woman would be pregnant, anastrozole may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control if you are not past menopause. Keep using birth control for at least 3 weeks after your last dose of Arimidex. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

How should I take Arimidex?

Take Arimidex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Arimidex is usually taken once per day. Follow your doctor’s dosing instructions very carefully.

You may take Arimidex with or without food.

You may need to keep taking this medication for up to 5 years. Follow your doctor’s instructions.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Breast Cancer:

Initial dose: 1 mg orally taken once a day
Duration of therapy: Until tumor progression (treatment of advanced breast cancer); unknown (adjuvant treatment of early breast cancer)

Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer;
-First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer;
-Second-line treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Arimidex side effects

Get emergency medical help if you have signs of an allergic reaction to Arimidex (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Anastrozole may decrease blood flow to your heart, especially if you have ever had coronary artery disease (clogged arteries). Seek medical attention if you have new or worsening chest pain, or if you feel short of breath.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• numbness, prickly feeling, pain, or weakness in your hands or wrists;
• symptoms of bone fracture – bruising, swelling, tenderness, pain that worsens with movement;
• liver problems – right-sided upper stomach pain, yellowing of your skin or eyes, and not feeling well; or
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common Arimidex side effects may include:

• numbness, tingling, or tickling feeling in your skin;
• hot flashes;
• weakness;
• joint pain or stiffness;
• bone pain, risk of fracture;
• swelling in your arms, legs, or feet;
• sore throat, cough, shortness of breath;
• headache, back pain;
• depression, sleep problems (insomnia);
• high blood pressure;
• nausea, vomiting; or
• rash.