What is azathioprine?

Azathioprine weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Azathioprine is used to prevent your body from rejecting a transplanted kidney. Azathioprine is also used to treat symptoms of rheumatoid arthritis.

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

Azathioprine 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.

Azathioprine may cause a serious brain infection 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.

Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of azathioprine may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

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

Warnings

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take azathioprine if you are allergic to azathioprine.

You should not use azathioprine to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking azathioprine, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using azathioprine for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using azathioprine.

How should I take azathioprine?

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

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.

When given for kidney transplant, azathioprine is usually given right before or on the day of transplant. For rheumatoid arthritis, azathioprine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using azathioprine as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if azathioprine upsets your stomach.

You may not be able to continue taking other arthritis medications together with azathioprine. Do not change your dose or dosing schedule without your doctor’s advice.

Azathioprine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking azathioprine?

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

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

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.

What is Revlimid?

Revlimid is a medication used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS) in adults. Revlimid helps to slow cancer growth, block new blood vessel growth in tumors, and help the immune system fight cancer. Revlimid is available as capsules that are taken once a daily.

Revlimid received FDA approval on December 27, 2005. The active ingredient, sometimes called the generic name, is lenalidomide.

This medicine is only available through a restricted distribution program called the Lenalidomide REMS program, as it may cause birth defects or embryo-fetal death.

What is Revlimid used for?

Revlimid is used for specific adult patients with:

Multiple Myeloma in combination with dexamethasone. Also, for multiple myeloma maintenance therapy in patients who have had an autologous hematopoietic stem cell transplantation (auto-HSCT).

Myelodysplastic Syndromes with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mantle Cell Lymphoma (MCL) that has relapsed or progressed after two prior therapies, one of which included bortezomib.

Previously treated Follicular Lymphoma (FL), used in combination with a rituximab product.

Previously treated Marginal Zone Lymphoma (MZL), used in combination with combination with a rituximab product.

Revlimid is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials.

Revlimid side effects

Common Revlimid side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• sleep problems, tiredness;
• weakness;
• headache;
• tremors;
• nosebleed;
• muscle cramps;
• joint pain;
• shortness of breath;
• fever, cough, tiredness;
• itching, rash, swelling; or
• stomach pain, nausea, vomiting, diarrhea, constipation.

Serious Revlimid side effects.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

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

• signs of a stroke or blood clot – sudden numbness or weakness, severe headache, problems with speech or vision, shortness of breath, swelling or redness in your arm or leg;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
• liver problems – upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts – fever, chills, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding;
• signs of a tumor getting worse – swollen glands, low fever, rash, or pain; or
• signs of tumor cell breakdown – lower back pain, blood in your urine, little or no urinating, numbness or tingly feeling around your mouth, muscle weakness or tightness, feeling short of breath, confusion, fainting.

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

Warnings

Never use Revlimid if you are pregnant. Even one dose of lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman.

For women: Use two forms of birth control, beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. See the ‘Before taking this medicine’ section for more information.

For men: Use a condom to prevent pregnancy during your treatment and for up to 4 weeks after your treatment ends. See the ‘Before taking this medicine’ section for more information.

Revlimid may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, coughing up blood, or swelling in your arm or leg.

Revlimid can lower blood cells that help your body fight infections and help your blood to clot. Call your doctor if you have unusual bruising or bleeding or signs of infection (fever, chills, body aches). You will need frequent blood tests while you are taking Revlimid.

Before taking this medicine

You should not use Revlimid if you are allergic to lenalidomide.

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

• an allergic reaction to thalidomide;
• kidney disease (or if you are on dialysis);
• liver disease;
• a blood clots or stroke;
• high blood pressure, high cholesterol or triglycerides;
• a thyroid disorder;
• lactose intolerance; or
• if you smoke.

Using Revlimid may increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.

Pregnancy

Revlimid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects in the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use Revlimid if you are pregnant. Tell your doctor right away if your period is late while taking Revlimid.

For Women: If you have not had a hysterectomy, you will be required to use two reliable forms of birth control, beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medicine. You must also have a negative pregnancy test 10 to 14 days before treatment and again 24 hours before. While you are taking Revlimid, you will have a pregnancy test every 2 to 4 weeks.

The birth control method you use must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner’s vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using Revlimid and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For Men: If a man fathers a baby while using Revlimid, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment and for up to 4 weeks after your treatment ends. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Breastfeeding

You should not breastfeed while using Revlimid.

How should I take Revlimid?

Take the medicine at the same time each day. You may take Revlimid with or without food.

Take each dose with a full glass of water. Swallow the capsule whole without breaking it open.

Lenalidomide can increase your risk of bleeding or infection. Your blood will need to be tested often.

Medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to handle and dispose of a broken capsule safely.

Take Revlimid exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or longer than recommended. Never share this medicine with another person, even if they have the same disorder you have.

Revlimid Dosing information

Usual Adult Revlimid Dose for Multiple Myeloma

Use: Multiple Myeloma in combination with dexamethasone
Dose: 25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity

Use: Maintenance therapy for Multiple Myeloma following auto-HSCT
Dose: 10 mg once a day continuously (Days 1 to 28 of repeated 28-day cycles) for 3 cycles, then increase to 15 mg once a day if tolerated until disease progression or unacceptable toxicity.

Comments:
For patients who are not eligible for auto-HSCT, therapy should continue until disease progression or unacceptable toxicity.
For patients who are eligible for auto-HSCT, hematopoietic stem cell mobilization should occur within 4 cycles.
Following auto-HSCT, initiate maintenance therapy after adequate hematologic recovery (ANC 1000/mcL or more AND/OR platelet count 75,000/mcL or more).
Consult the manufacturer’s product information for dexamethasone dosing recommendations.

Usual Adult Dose for Myelodysplastic Disease:

Dose: 10 mg orally once a day; therapy is continued or modified based on clinical and laboratory findings until disease progression or unacceptable toxicity
Use: Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Usual Adult Dose for Lymphoma:

Follicular Lymphoma or Marginal Zone Lymphoma:
Dose: 20 mg orally once a day on Days 1 through 21 of repeated 28-day cycles for up to 12 cycles in combination with a rituximab product.
Use: In combination with a rituximab product for the treatment of previously treated follicular lymphoma (FL). In combination with a rituximab product for the treatment of previously treated marginal zone lymphoma (MZL).

Mantel Cell Lymphoma:
Dose: 25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity; treatment is continued, modified, or discontinued based on clinical and laboratory findings.
Use: The treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Revlimid is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up for the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

You must not donate blood or sperm while you are using Revlimid, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

This medicine 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 other drugs will affect Revlimid?

Tell your doctor if you also use pembrolizumab (Keytruda).

If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are certain drugs that can make hormonal birth control less effective in your body. Tell your doctor about all other medicines you use. You may need to replace your hormonal birth control method with another effective form of contraception.

Other drugs may interact with lenalidomide, 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.

Revlimid Package Insert

Review the Revlimid Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Handling and Disposal

Care should be exercised in the handling of this medicine. Capsules should not be opened or broken. If powder from capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If Revlimid contacts the mucous membranes, flush thoroughly with water. Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.

Ingredients

Active ingredient: lenalidomide

Inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

The 5 mg and 25 mg capsule shells contain gelatin, titanium dioxide, and black ink.

The 2.5 mg and 10 mg capsule shells contain gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide, and black ink.

The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide, and black ink.

The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.

Storage

Store at 20°C – 25°C (68°F – 77°F)