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REVLIMID DS 20 MG CAP 100

  • Manufacturer Name : Bristol Myers
  • MFG # : 59572042000
  • NDC : 59572042000
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category S
Drug Type Code 1
FDA Approval Date 06/05/2013
FDA Therap Equiv AB
HCPCS -
Market Entry Date 06/18/2013
Medical Coverage -
Termination Date -
Unit CAP
Units Per Pkg 100
Active Ingredients 11171 lenalidomide 191732726
AHFS Class 10000000 ANTINEOPLASTIC AGENTS; 92200000 IMMUNOMODULATORY AGENTS
DEA Class NC
Dose Form CAPSULE
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 71056 lenalidomide ORAL CAPSULE 20 MG
Inactive Ingredients 10138 blue dye; 2432 lactose 64044515; 2549 gelatin 9000708
OMP Family -
Product Category RX Pharmaceuticals
Strength 20MG
Common Brand Name COMMON BRAND NAME(S): Revlimid
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Case Quantity 72
Drug Form Pack Size 100
Form CAPSULES
Hazard Code -
Listed Chemical -
NIOSH Code NT1 ANTINEOPLASTIC DRUGS INCLUDING THOSE WITH MANUFACTURER'S SAFE HANDLING GUIDANCE (MSHG)
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Not Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking lenalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. For treatment of certain conditions, you may be instructed to take this medication in cycles (once daily for 21 days, then stopping the medication for 7 days). The dosage is based on your medical condition, response to treatment, and lab test results. Be sure to follow your doctor's directions carefully. Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug. Use this medication regularly to get the most benefit from it. Remember to take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as complete blood count, kidney/liver/thyroid function, blood mineral levels, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (LEN-a-LID-oh-mide)
Precautions PRECAUTIONS: See also Warning section. 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 (such as lactose), 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: kidney disease, liver disease (such as hepatitis B), thyroid disease, chicken pox and shingles (herpes zoster infection), organ transplant. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Lenalidomide can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using lenalidomide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Do not donate blood or sperm while using lenalidomide and for 4 weeks after stopping this drug. Older adults may be more sensitive to the side effects of this drug. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. Lenalidomide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, stop taking lenalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who is or can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away. It is unknown if lenalidomide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of appetite, constipation, dizziness, dry skin, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), increased thirst/urination, shaking (tremor), numbness/tingling of arms/legs, fast/slow/irregular heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Some people treated with this medication may rarely get other cancers. Consult your doctor for more details. Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness. People taking lenalidomide may have worsening of their symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor right away. This drug helps many people live longer. However, some people who have used lenalidomide have died sooner than expected, especially if they had high white blood cell or tumor cell counts. Talk with your doctor about the risks and benefits of using this medication. Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions. Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.

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REVLIMID DS 20 MG CAP 100 is manufactured by Bristol Myers.
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