What is gemcitabine?

Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast.

Gemcitabine is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working.

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

Gemcitabine 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.

Also call your doctor at once if you have:

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• blisters or ulcers in your mouth, trouble eating or swallowing;
• severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
• liver problems–loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts–fever, chills, tiredness, skin sores, cold hands and feet, feeling light-headed;
• fluid build-up in or around the lungs–pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
• signs of damaged red blood cells–unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

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

Common side effects of gemcitabine may include:

• fever;
• nausea, vomiting;
• low blood cell counts;
• abnormal blood or urine tests;
• shortness of breath;
• swelling in your hands or feet;
• rash; or
• red or pink urine.

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

Gemcitabine can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness, bruising or bleeding, pale skin).

Gemcitabine can also affect your liver, kidneys, or lungs. Tell your doctor if you have stomach pain, dark urine, yellow skin or eyes, little or no urinating, swelling, rapid weight gain, severe shortness of breath, wheezing, or cough with foamy mucus.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Before taking this medicine

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

Tell your doctor if you have ever had:

• kidney disease;
• liver disease (especially cirrhosis);
• alcoholism; or
• radiation treatment.

Both men and women using gemcitabine should use effective birth control to prevent pregnancy. Gemcitabine can harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not use gemcitabine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using gemcitabine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby.

You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose.

How is gemcitabine used?

Gemcitabine is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when gemcitabine is injected.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

Gemcitabine can increase your risk of bleeding or infection. You will need frequent medical tests.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using gemcitabine?

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Do not receive a “live” vaccine while using gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect gemcitabine?

Other drugs may affect gemcitabine, 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 Gemzar?

Gemzar is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Gemzar is used to treat cancers of the pancreas, lung, ovary, and breast.

Gemzar is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working.

Warnings

Gemzar can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness, bruising or bleeding, pale skin).

Gemzar can also affect your liver, kidneys, or lungs. Tell your doctor if you have stomach pain, dark urine, yellow skin or eyes, little or no urinating, swelling, rapid weight gain, severe shortness of breath, wheezing, or cough with foamy mucus.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Before receiving Gemzar

You should not use Gemzar if you are allergic to gemcitabine.

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

• kidney disease;
• liver disease (especially cirrhosis);
• alcoholism; or
• radiation treatment.

Both men and women using Gemzar should use effective birth control to prevent pregnancy. Gemcitabine can harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not use Gemzar if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using gemcitabine.

Gemzar may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby.

You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose.

How is Gemzar used?

Gemzar is injected into a vein as an IV infusion. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Gemzar is injected.

If any Gemzar injection accidentally gets on your skin, wash the area thoroughly with soap and warm water.

Gemcitabine can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

What happens if I miss a dose?

Contact your doctor if you miss a miss an appointment to receive your Gemzar infusion.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Do not receive a “live” vaccine while using Gemzar, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Gemcitabine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Gemzar side effects

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

If you receive Gemzar during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Also call your doctor at once if you have:

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• blisters or ulcers in your mouth, red or swollen gums, trouble eating or swallowing;
• severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
• liver problems – loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts – fever, chills, tiredness, skin sores, cold mhands and feet, feeling light-headed;
• fluid build-up in or around the lungs – pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
• signs of damaged red blood cells – unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

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

Common Gemzar side effects may include:

• fever;
• nausea, vomiting;
• low blood cell counts;
• abnormal blood or urine tests;
• shortness of breath;
• swelling in your hands or feet;
• mild rash; or
• red or pink urine.

What is Hydrea?

Hydrea is used to treat chronic myeloid leukemia, ovarian cancer, and certain types of skin cancer (squamous cell cancer of the head and neck).

Hydrea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. This medicine will not cure sickle cell anemia.

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

Hydrea side effects

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

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

• numbness, tingling, or burning pain in your hands or feet;
• skin numbness or purple discoloration;
• skin ulcers or open sores;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low blood cell counts–fever, chills, tiredness, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or
• signs of liver or pancreas problems–loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Hydrea may include:

• loss of appetite, nausea;
• constipation, diarrhea;
• low blood cell counts;
• bleeding; or
• mouth sores.

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

Both men and women using Hydrea should use birth control to prevent pregnancy. The use of Hydrea by either parent may cause birth defects.

Using Hydrea may increase your risk of developing other types of cancer, such as leukemia or skin cancer. Wear protective clothing and use sunscreen when you are outdoors.

Hydrea can weaken your immune system. Call your doctor at once if you have a fever, chills, body aches, extreme tiredness, shortness of breath, bruising, or unusual bleeding.

Before taking this medicine

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

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• liver disease;
• a wound or ulcer on your leg;
• HIV or AIDS (especially if you take antiviral medicine);
• high levels of uric acid in your blood; or
• treatment with an interferon, chemotherapy, or radiation.

Using Hydrea may increase your risk of developing other types cancer or leukemia. Talk with your doctor about your specific risk.

Hydrea can harm an unborn baby. Both men and women using this medicine should use birth control to prevent pregnancy. The use of this medicine by either parent may cause birth defects.

• If you are a woman, keep using birth control for at least 6 months after your last dose of Hydrea.
• If you are a man, keep using birth control for at least 1 year after your last dose (6 months if you took Siklos).
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control because Hydrea may harm the baby if a pregnancy does occur.

You should not breastfeed while you are taking Hydrea.

Older adults may be more sensitive to the effects of this medicine.

How should I take Hydrea?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Hydrea is usually taken once per day at the same time of day, with or without food. Swallow the pill whole with a glass of water.

Wash your hands before and after you handle Hydrea or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills.

Do not open the Hydrea capsule or crush or chew a tablet. Do not use a broken pill. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from a broken pill is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Your doctor may also want you to take a folic acid supplement. Follow dosing instructions very carefully.

Hydrea can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Hydrea.

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

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 .

Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.

What should I avoid while taking Hydrea?

Using Hydrea may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a “live” vaccine while using Hydrea, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not handle Hydrea pills or the medicine bottle without skin protection (disposable gloves).

What other drugs will affect Hydrea?

Some medicines can increase your risk of serious side effects while taking Hydrea. Tell your doctor if you are also using antiviral medicine or an interferon.

Other drugs may affect Hydrea, 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 hydroxyurea?

Hydroxyurea is used to treat chronic myeloid leukemia, ovarian cancer, and certain types of skin cancer (squamous cell cancer of the head and neck).

Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.

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

Hydroxyurea side effects

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

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

• numbness, tingling, or burning pain in your hands or feet;
• skin numbness or purple discoloration;
• skin ulcers or open sores;
• sudden chest pain, wheezing, dry cough, feeling short of breath;
• low blood cell counts–fever, chills, tiredness, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or
• signs of liver or pancreas problems–loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of hydroxyurea may include:

• loss of appetite, nausea;
• constipation, diarrhea;
• low blood cell counts;
• bleeding; or
• mouth sores.

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

Both men and women using hydroxyurea should use birth control to prevent pregnancy. The use of hydroxyurea by either parent may cause birth defects.

Using hydroxyurea may increase your risk of developing other types of cancer, such as leukemia or skin cancer. Wear protective clothing and use sunscreen when you are outdoors.

Hydroxyurea can weaken your immune system. Call your doctor at once if you have a fever, chills, body aches, extreme tiredness, shortness of breath, bruising, or unusual bleeding.

Before taking this medicine

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

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• liver disease;
• a wound or ulcer on your leg;
• HIV or AIDS (especially if you take antiviral medicine);
• high levels of uric acid in your blood; or
• treatment with an interferon, chemotherapy, or radiation.

Using hydroxyurea may increase your risk of developing other types cancer or leukemia. Talk with your doctor about your specific risk.

Hydroxyurea can harm an unborn baby. Both men and women using this medicine should use birth control to prevent pregnancy. The use of this medicine by either parent may cause birth defects.

• If you are a woman, keep using birth control for at least 6 months after your last dose of hydroxyurea.
• If you are a man, keep using birth control for at least 1 year after your last dose (6 months if you took Siklos).
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control because hydroxyurea may harm the baby if a pregnancy does occur.

You should not breastfeed while you are taking hydroxyurea.

Older adults may be more sensitive to the effects of this medicine.

How should I take hydroxyurea?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Hydroxyurea is usually taken once per day at the same time of day, with or without food. Swallow the pill whole with a glass of water.

Wash your hands before and after you handle hydroxyurea or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills.

Do not open the hydroxyurea capsule or crush or chew a tablet. Do not use a broken pill. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from a broken pill is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

Your doctor may also want you to take a folic acid supplement. Follow dosing instructions very carefully.

Hydroxyurea can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using hydroxyurea.

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

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 .

Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.

What should I avoid while taking hydroxyurea?

Using hydroxyurea may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a “live” vaccine while using hydroxyurea, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What is Mavenclad?

Mavenclad is a purine antimetabolite that interferes with enzymes that are necessary for DNA synthesis.

Mavenclad is used to treat relapsing multiple sclerosis (MS) in adults. This medicine will not cure MS, it will only decrease the frequency of relapse symptoms.

Mavenclad is usually given after other treatments have failed.

Mavenclad side effects

Common Mavenclad side effects may include:

• headache;
• low white blood cell counts; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Serious side effects

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

Mavenclad may cause a serious brain infection called Progressive multifocal leukoencephalopathy (PML) that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mavenclad may decrease counts of lymphocytes and other types of blood cells. Your healthcare provider will obtain a blood test before starting treatment, 2 and 6 months after starting treatment, periodically thereafter, and when clinically needed. Keep all appointments for lymphocyte monitoring.

Taking Mavenclad may increase your risk of infections caused by bacteria, viruses, parasites, or fungi that may be life-threatening or cause death.

Also, call your doctor at once if you have:

• heart problems – swelling, rapid weight gain, feeling short of breath;
• low blood cell counts – fever, swollen glands, stomach pain, cough, runny nose, joint pain, mouth sores, skin sores or rash, easy bruising, unusual bleeding;
• liver problems – nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of your skin or eyes, dark urine. Mav;enclad can cause liver injury
• signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body; or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired
• signs of an infection – such as fever, aching, painful muscles, headache, generally feeling unwell, or loss of appetite.

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

Do not take Mavenclad if you are pregnant. Both men and women should use effective birth control to prevent pregnancy while taking Mavenclad, and for 6 months after the last dose.

If you use birth control pills or other hormonal forms (implants, skin patches, vaginal rings), also use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while taking Mavenclad and for at least 4 weeks after your treatment course ends.

Taking cladribine may increase your risk of developing certain cancers.

Before taking this medicine

You should not take Mavenclad if you are allergic to cladribine, or if you have:

• cancer;
• an active infection such as tuberculosis or hepatitis B or C;
• moderate-to-severe liver impairment (Child-Pugh score greater than 6)
• HIV or AIDS; or
• if you are pregnant or breastfeeding.

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

• an active or chronic infection;
• heart problems;
• weak immune system (caused by disease or by using certain medicine);
• liver or kidney disease;
• cancer; or
• if you receive blood transfusions.

Tell your doctor if you have recently received a vaccine (within 4 to 6 weeks before you take Mavenclad).

Taking cladribine may increase your risk of developing certain cancers. Ask your doctor about this risk.

Do not take Mavenclad if you are pregnant. Cladribine could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

• Cladribine can harm an unborn baby if the mother or the father is using this medicine.
• If you are a woman taking Mavenclad, you may need to have a negative pregnancy test before starting this medicine. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man taking Mavenclad, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking this medicine.

Mavenclad can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while taking this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using the second form of birth control for at least 4 weeks after your Mavenclad treatment course ends.

Do not breastfeed while taking cladribine, and for at least 10 days after your last dose.

How should I take Mavenclad?

Take Mavenclad 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.

Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using Mavenclad.

Mavenclad is taken in 2 treatment courses separated by about a year. There are 2 treatment cycles in each course. During each cycle, you will take the medicine for 4 or 5 days in a row. The 2 cycles are separated by about a month. Follow your doctor’s dosing instructions very carefully.

Your doctor will determine how many treatment courses you should receive.

Take this medicine with a full glass of water. You may take Mavenclad with or without food.

Use dry hands to remove a tablet from the foil blister pack when you are ready to take the medicine.

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

Wash your hands after handling the tablet.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your eyes or nose, or on your skin. If this happens, rinse thoroughly with water. Ask your pharmacist how to safely dispose of a broken pill.

You may be given other medications to help prevent infections. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat.

Cladribine can have long lasting effects on your body. Your doctor will need to check your progress on a regular basis and for another 2 years after your last dose.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. If the day is almost over before you remember your dose, wait until the next day to take it.

Do not take 2 doses in one day. Take your next dose at the regular time and stay on your once-daily schedule, even if it adds an extra day to your treatment cycle for the week.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not receive a “live” vaccine while using Mavenclad. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Your doctor will determine when it is safe for you to receive a vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Cladribine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat leukemia and certain types of cancer of the breast, skin, head and neck, lung, or uterus.

Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis in adults. It is also used to treat active polyarticular-course juvenile rheumatoid arthritis in children.

Methotrexate is sometimes given when other medicines have not been effective.

Methotrexate side effects

Common side effects of methotrexate

Common methotrexate side effects may include:

• fever, chills, tiredness, not feeling well;
• low blood cell counts;
• mouth sores;
• nausea, stomach pain;
• abnormal liver function tests;
• hair loss;
• burning skin lesions; or
• being more sensitive to light.

Serious methotrexate side effects

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

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

• sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
• fever, chills, swollen lymph glands, night sweats, weight loss;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• vomiting, diarrhea, blood in your urine or stools;
• skin changes such as redness, warmth, swelling, or oozing;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• kidney problems – little or no urination, swelling in your feet or ankles;
• liver problems – swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• nerve problems – confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

This is not a complete list of side effects and others may occur.

Warnings

Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. Methotrexate is sometimes used to treat cancer during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Do not use this medicine to treat psoriasis or rheumatoid arthritis if you have low blood cell counts, a weak immune system, alcoholism or chronic liver disease, or if you are breastfeeding.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. Some people have died after incorrectly taking methotrexate every day. You must use the correct dose for your condition.

Methotrexate can cause serious or fatal side effects. Tell your doctor if you have diarrhea, mouth sores, cough, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizure, or skin rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use methotrexate if you are allergic to it. You may not be able to take this medicine if you have:

• alcoholism, cirrhosis, or chronic liver disease;
• low blood cell counts;
• a weak immune system or bone marrow disorder; or
• if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

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

• liver problems, especially fluid in your stomach (ascites);
• kidney disease;
• lung problems, especially fluid in the lungs (pleural effusion);
• radiation treatments; or
• a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

How should I take methotrexate?

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. This medicine is sometimes taken only once per week, or 2 to 4 times per week. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.

You must use the correct dose. Some people have died after incorrectly taking methotrexate every day.

Take methotrexate exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray. Your cancer treatments may be delayed based on the results.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

Store methotrexate at room temperature away from moisture, heat, and light.

You may store Xatmep in a refrigerator or at room temperature. Avoid freezing or high heat. Throw away any unused Xatmep after 60 days if kept at room temperature.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of methotrexate can be fatal.

Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What to avoid

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a “live” vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate 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.