Revlimid

DRUG DESCRIPTION

REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-l-oxo l,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:

REVLIMID
  (lenalidomide) Structural Formula Illustration

3-(4-amino-l-oxo l,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione

The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3.

Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero.

REVLIMID is available in2.5 mg, 5 mg, 10 mg, 15 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains 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.

What are the possible side effects of lenalidomide (Revlimid)?

Stop using lenalidomide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, sudden shortness of breath, coughing up blood;
  • pain or swelling in your arm, thigh, or calf;
  • easy bruising, unusual bleeding or weakness;
  • fever, chills, body aches, flu symptoms;
  • lower back pain, blood in your...

Read All Potential Side Effects and See Pictures of Revlimid

What are the precautions when taking lenalidomide (Revlimid)?

Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: multiple myeloma, kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using...

Read All Potential Precautions of Revlimid


Revlimid Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, tiredness, dizziness, dry skin, constipation, stomach pain, vomiting, dry mouth, unpleasant taste, loss of appetite, headache, trouble sleeping, or painful urination may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, pounding heartbeat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: multiple myeloma, kidney disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using lenalidomide.

Because lenalidomide can cause severe birth defects or death to an unborn baby, several precautions are noted below.

Do not donate blood while using lenalidomide and for 4 weeks after stopping this drug.

It is unknown if this drug can be absorbed through the skin. Handle the capsules carefully. Caution is advised if you come in contact with the contents of a broken capsule. If this occurs, wash your hands thoroughly with soap and water.

Males - Always use a latex condom when having sexual intercourse with a woman of childbearing age, even if you have had a vasectomy. You must not donate sperm while using lenalidomide and for 4 weeks after stopping this drug.

Use two forms of effective birth control together for at least 4 weeks before beginning lenalidomide treatment, during lenalidomide treatment, and for 4 weeks after stopping lenalidomide, or avoid intercourse completely during this period. Reliable birth control is necessary even if you have been unable to get pregnant in the past. Consult your doctor for more information about the right forms of birth control to use during this therapy.

Immediately tell your doctor if your period is late or if you have abnormal vaginal (menstrual) bleeding.

Lenalidomide must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Even a single dose of lenalidomide taken during pregnancy can cause severe birth defects. If pregnancy does occur during treatment, this drug must be stopped immediately.

It is not known whether this drug passes into breast milk. Because of the potential for serious reactions in nursing infants, breast-feeding is not recommended while using lenalidomide.


Revlimid Patient Information Including Side Effects

Brand Names: Revlimid

Generic Name: lenalidomide (Pronunciation: LEN a LID o mide)

  • What is lenalidomide (Revlimid)?
  • What are the possible side effects of lenalidomide (Revlimid)?
  • What is the most important information I should know about lenalidomide (Revlimid)?
  • What should I discuss with my healthcare provider before taking lenalidomide (Revlimid)?
  • How should I take lenalidomide (Revlimid)?
  • What happens if I miss a dose (Revlimid)?
  • What happens if I overdose (Revlimid)?
  • What should I avoid while taking lenalidomide (Revlimid)?
  • What other drugs will affect lenalidomide (Revlimid)?
  • Where can I get more information?

What is lenalidomide (Revlimid)?

Lenalidomide affects the immune system. It helps promote immune responses to prevent inflammation in the body.

Lenalidomide treats anemia (a lack of red blood cells in the body) and multiple myeloma (cancer resulting from a progressive blood disease). It is used in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.

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

What are the possible side effects of lenalidomide (Revlimid)?

Stop using lenalidomide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, sudden shortness of breath, coughing up blood;
  • pain or swelling in your arm, thigh, or calf;
  • easy bruising, unusual bleeding or weakness;
  • fever, chills, body aches, flu symptoms;
  • lower back pain, blood in your urine;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;
  • severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • nausea, diarrhea, constipation;
  • dry or itchy skin;
  • runny or stuffy nose;
  • muscle or joint pain;
  • headache; or
  • tiredness.

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 at 1-800-FDA-1088.

What is the most important information I should know about lenalidomide (Revlimid)?

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use lenalidomide if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking lenalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.

Stop using lenalidomide 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.

For Men: You must not cause a woman to become pregnant while you are taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby. 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.

Lenalidomide is available only under a special program called RevAssist. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give lenalidomide to another person, even if he or she has the same disorder for which you are being treated.

Do not donate blood or sperm while you are using lenalidomide.

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