Revlimid package insert pdf file

Apr 01, 2020 revlimid can cause severe, lifethreatening 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. Revlimid lenalidomide is a prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma a type of cancer of. Lenvima lenvatinib eisai assistance program enrollment. Symbicort budesonide and formoterol fumarate dihydrate inhalation aerosol, for oral inhalation use. Uninsured uninsured if you do not have health insurance or enough coverage to pay for revlimid, the celgene patient assistance program pap may be able to provide you with revlimid at no cost. Highlights of prescribing information tafinlar with. Revlimid should not be used to treat people who have chronic lymphocytic. A study showed that adding ninlaro to revlimid lenalidomide and dexamethasone improved median progressionfree survival pfs by nearly 6 months 20. Multiple myeloma mm, in combination with dexamethasone. Multi ingredient medications may also be listed when applicable.

Learn about ninlaro, including efficacy, safety, dosing, and patient support. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication. Full prescribing information 1 indications and usage aptiom is indicated for the treatment of partialonset seizures in patients 4 years of age and older. Patients should not break, chew or open the capsules. Sections or subsections omitted from the full prescribing information are not listed.

Administer synthroid at least 4 hours before or after drugs known to interfere with synthroid absorption see drug interactions 7. Revlimid is a drug marketed by celgene and is included in one nda. Mm, as maintenance following autologous hematopoietic stem cell transplantation autohsct. Daratumumab intravenous infusion on days 1, 8, 15, and 22 of cycles 1 and 2, then days 1 and 15 of cycles 3 through 6, then monthly thereafter. Ilaris canakinumab for injection, for subcutaneous use ilaris canakinumab injection, for subcutaneous use initial u. Revlimid is only available through a restricted distribution program. Tap along the timeline to move to different parts of the audio file. In studies of both healthy volunteers and subjects with hansens disease, the mean. The absolute bioavailability of thalidomide from thalomid thalidomide capsules has not yet been characterized in human subjects due to its poor aqueous solubility. Starting dose adjustment for renal impairment in mm. Symbicort is indicated for the treatment of asthma in patients 6 years of age and older. If you do not file taxes, alternate documents are acceptable such as w2 form, social security statement or pay stubs.

The recommended starting dose of revlimid is 25 mgday orally on days 121 of repeated 28day. Revlimid lenalidomide a treatment option for multiple. Revlimid should not be used to treat people who have chronic lymphocytic leukemia cll unless. For further information on revlimid, please refer to the full prescribing information revlimid dose quantity directions 2.

It is used to treat multiple myeloma, certain types of lymphoma, and some myelodysplastic syndromes that cause severe anemia requiring blood transfusions. Ninlaro ixazomib is the first and only oral medication of its kind, a proteasome inhibitor, that you can take at home. Revlimid, innlenalidomide european medicines agency. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion.

After treatment, patients who respond to rvd typically are either monitored, continue on to maintenance therapy, or proceed to bone marrow transplant. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. Financial help for revlimid lenalidomide celgene patient. For the most recent pi, please refer to the tga website at.

Click the link below that best describes your insurance situation. Revlimid is indicated as maintenance therapy in patients with mm following autologous hematopoietic stem cell transplantation autohsct. Please see indication and important safety information. Celgene, expanding its use, in combination with lowdose dexamethasone, for the firstline treatment of patients with newly diagnosed multiple myeloma. Revlimid complete drug information, side effects and. Highlights of prescribing information these highlights do not include all the information needed to use ilaris safely and effectively. Revlimid lenalidomide now fda approved as firstline. Revlimid cost lenalidomide posted by mitch fraker see editorial guidelines is your revlimid medication too expensive. Even if you dont have insurance or enough coverage to pay for your medicine, financial help may be available.

Return to at least 1,000mcl if patient starting dose was 20 mg daily, resume revlimid at 5 mg less than the previous dose. Kyprolis carfilzomib is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. As i have noted here before, i met a woman at the nottingham infoday who has been on revlimid for 5 coming on 6 years, it simply works for her with a minimum of sideeffects. See important safety information and prescribing information. Common side effects include diarrhea, itchiness, join pain, fever, headache. Lenvima lenvatinib eisai assistance program enrollment form page 3 patient authorization for health information and disclosure i authorize my health care providers and health insurers to disclose to eisai inc. Nphthalimido glutarimide, is an immunomodulatory agent. Review the prescribing information for nivolumab for full dosing and schedule information. If patient starting dose was 10 mg daily, resume at 5 mg less than previous dose. These highlights do not include all the information needed to use. Darzalex is a prescription medicine used to treat adults with multiple myeloma. Tecentriq atezolizumab injection, for intravenous use initial u. For mm it is used after at least one other treatment and generally together with dexamethasone. After initiation of revlimid therapy, subsequent revlimid dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.

This emedtv article presents an indepth look at this medication, with details on specific uses of the drug, dosing instructions, potential side effects, and more. Click on the revlimid lenalidomide package insert below for reported side effects and possible drug interactions. Lenalidomide approved as firstline therapy in multiple myeloma. Your doctor will enroll you in the revlimid rems program so that you can receive your medication.

However, the capsules are 90% bioavailable relative to an oral peg solution. The recommended starting dose of revlimid is 25 mg once daily on days 121 of repeated 28day cycles. Referenced with permission from the nccn clinical practice guidelines in oncology. For further information on revlimid, please refer to the full prescribing information tape prescription here prior to faxing referral, or complete the following. Learn about opdivo nivolumab, a prescription medicine that treats certain types of cancers. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for revlimid lenalidomide. Refer to the dexamethasone and lenalidomide prescribing information for additional. Even if you dont have insurance or enough coverage to pay for. Revlimid prior authorization form upmc health plan. We care about making sure you get the help you need to start your treatment. Use the materials below to learn more about the revlimid rems program, and what you need to. At celgene patient support, we care about making sure you get the answers you need. Highlights of prescribing information when administering.

Rvd or vrd treatment for multiple myeloma chemoexperts. This drug has three hundred and ninetythree patent family members in forty countries. Revlimid is used to treat certain bone marrow diseases and cancers. The recommended dose of dexamethasone is 40 mg once daily on days 14, 912, and 1720 of each 28day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on days 14 every 28 days. You may report side effects to the fda at 1800fda1088. The solubility of lenalidomide in water and at ph 1.

The generic ingredient in revlimid is lenalidomide. A treatment option for multiple myeloma revlimid lenalidomide. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marg inal zone lymphoma mzl. Corporation at 18884235436 or fda at 1800fda1088 or. Jun 06, 2019 revlimid has demonstrated a significantly increased risk of deep vein thrombosis dvt and pulmonary embolism pe, as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with revlimid and dexamethasone therapy. Initially, 25 mg once daily given on days 121 of each 28day cycle. For concomitant therapy doses, see full prescribing information 2.

View physician videos discussing treatment with ninlaro. These highlights do not include all the information needed to use symbicort safely and effectively. Revlimid should be taken orally at about the same time each day, either with or without food. Lenalidomide, sold under the trade name revlimid among others, is a medication used to treat multiple myeloma mm and myelodysplastic syndromes mds. Lenalidomide is a chemotherapy drug that targets specific proteins within cancer cells and stops the cancer cell from growing. Multiple myeloma disease trajectory kyprolis carfilzomib. For other grade 34 toxicities judged to be related to revlimid, hold treatment and restart at the physicians discretion at next lower dose level when toxicity has resolved to. In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells autologous stem cell transplant and in people who have received at.

Download leaflet view the patient leaflet in pdf format. Revlimid lenalidomide is a prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma a type of cancer of the bone marrow who already have had. Revlimid is the first oral medication developed for treatment of myeloma, and it is taken in capsule form. Please see accompanying full prescribing information, including oxed warnings.

Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect synthroid absorption see drug interactions 7. Revlimid lenalidomide is a prescription medicine, used to treat adults with multiple myeloma mm in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation a type of stem cell transplant that uses your own stem cells. Extended survival and reduced risk of aml progression in erythroidresponsive lenalidomidetreated. The empirical formula for thalidomide is ch10n2o4 and the gram molecular weight is 258. Highlights of prescribing information these highlights do not include all the information needed to use zerbaxasafely and effectively. Empliciti elotuzumab, when used with pd or rd, is a prescription treatment for certain adults with relapsed or refractory multiple myeloma. There are twenty patents protecting this drug and three paragraph iv challenges. There are fourteen drug master file entries for this.

Afinitor is not for use in people with carcinoid tumors that actively produce hormones. Even one dose of lenalidomide can cause major birth defects of the babys arms and legs, bones, ears, eyes, face, and heart. Revlimid in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma mzl. Thats why our specialists are ready to help answer questions about the insurance approval process, and the financial help that may be available for your revlimid.

Certified pharmacy ships revlimid to patient with medication guide information about revlimid and the revlimid rems program can be obtained by calling the celgene customer care center tollfree at 18884235436, or at. Nov 07, 2019 revlimid is a thalidomide analogue indicated for the treatment of adult patients with. Highlights of prescribing information these highlights do not include all the information needed to use pomalyst safely and effectively. Revlimid prior authorization form if this is an urgent request, please call upmc health plan pharmacy services. On february 18, 2015, the us food and drug administration fda approved a new indication for lenalidomide revlimid.

Revlimid is not indicated and is not recommended for the treatme nt of patients with cll outside of controlled clinical trials see warnings and precautions 5. Revlimid capsules should be swallowed whole with water. Programs that may be able to help you with the cost of revlimid differ by the type of insurance you have. Monitor for and advise patients about signs and symptoms of thromboembolism. Revlimid is a thalidomide analogue indicated for the treatment of adult patients with. Darzalex is a cd38directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma 1. If you are not sure, you can call your specialist at 1. Opdivo nivolumab information for healthcare professionals. Highlights of prescribing information these highlights do not include all the information needed to use tecentriq safely and effectively. Find patient medical information for revlimid oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Common side effects include diarrhea, itchiness, join pain, fever, headache, and trouble sleeping.