If lenalidomide is used during pregnancy, it may cause birth defects or embryofetal death. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. In females of reproductive potential, obtain 2 negative pregnancy. Higher mortality rates at the 10 mgkg dose and higher rates of cardiovascular events at the 5 mgkg dose have been observed in these patients. Corlanor ivabradine tablets, for oral use corlanor ivabradine oral solution initial u. Highlights of prescribing information 5 mgkg at 0, 2. Gleevec imatinib mesylate tablets, for oral use initial u. These highlights do not include all the information needed to use tamiflu safely and effectively. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and. Benlysta should not be infused concomitantly in the same intravenous line with other agents. Inflectra infliximab dyyb for injection for health care professionals. Remicade, inflectra infliximab, infliximab dyyb remicade inflectra fep clinical rationale the use of tocilizumab in combination with biological dmards such as tnf antagonists, including remicade and inflectra, should be avoided because of the possibility of increased.
Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. Remicade remeh kaid infliximab lyophilized concentrate for injection, for intravenous use read the medication guide that comes with remicade before you receive the first treatment, and before each time you get a treatment of remicade. Patients treated with remicade should be given the package leaflet and the patient reminder card. Serious infections leading to hospitalization or death including. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. The dose for ra in combination with methotrexate is two mg intravenous infusions separated by 2 weeks one course every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of benlysta with other agents.
This leaflet answers some common questions about remicade. Please read the full prescribing information and medication guide for remicade and discuss any. Remicade is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active crohns disease who have had an inadequate response to conventional therapy. Renflexis can block the damage caused by too much tnfalpha. Risk of serious infections see full prescribing information for complete boxed warning. Pregnancy must be excluded before start of treatment. Renflexis infliximababda is biosimilar to remicade. Entyvio vedolizumab for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients. Ask your doctor if you are not sure if your medicine is one listed above. Remicadeinfusions should beadministered by qualified healthcare professionals trained to detect any infusionrelated issues. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis tb and histoplasmosis.
These highlights do not include all the information needed to use renflexis safely and effectively. Renflexis blocks the action of a protein in your body called tumor necrosis factoralpha tnfalpha. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for remicade infliximab skip to. Lyophilized concentrate for injection, for intravenous use. Information for the user remicade 100 mg powder for concentrate for solution for infusion infliximab read all of this leaflet carefully before you start using this medicine because it contains important information for you.
The other cases represented a variety of malignancies, including rare malignancies. Inflectra infliximabdyyb is biosimilar to remicade infliximab for the indications. However, since cmv usually causes latent infections and since foscarnet, like. Highlights of prescribing information these highlights do not include allthe information needed to use corlanorsafely and effectively. Enbrel etanerceptinjection, for subcutaneous use enbrel etanercept for injection, for subcutaneous use initial u. Actemra subcutaneous formulation is not intended for. Remicade is a prescription medicine that is approved for patients with. Downloading fda package insert for remicade injection. Remicade, inflectra infliximab, infliximabdyyb rationale. Highlights of prescribing information who initially respond. Insert the syringe needle into the vial through the centre of the rubber stopper and direct the. Highlights of prescribing information 5 mgkg at 0, 2 and 6.
Only your doctor can recommend a course of treatment after checking your health condition. Remicade is also approved to treat crohns disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. Remicade infliximab hcp information for healthcare. Cimzia certolizumab pegol an fdaapproved biologic treatment.
It does not take the place of talking to your doctor. Remicade, inflectra infliximab, infliximab dyyb remicade inflectra fep clinical rationale rationale for inclusion in pa program background remicade and inflectra are tumor necrosis factor tnf. Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Patients treated with remicade should be given the package leaflet and the patient reminder. Simponi is a medicine that affects your immune system. Renflexis fda prescribing information, side effects and uses. Do not use if the oxygen indicator has turned blue or purple before opening the package see how suppliedstorage and handling 16. Serious infections and malignancy see full prescribing information for complete boxed. Menveo is approved for use in persons aged 2 months through 55 years. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis tb and histoplasmosis. Highlights of prescribing information for psoriatic. Highlights of prescribing information 5 mgkg at 0, 2 and. Inflectra is contraindicated in patients with moderate to severe nyha class iiiiv congestive heart failure chf at doses greater than 5 mgkg. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively.
Highlights of prescribing information who initially. The remicade pediatric ulcerative colitis uc trial was a multicenter, phase 3, randomized, openlabel, parallelgroup trial to evaluate the safety and efficacy of remicade in pediatric patients aged 6 to 17 years with moderately to severely active uc n60. Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active crohns disease who havent responded well to other therapies. Can reduce signs and symptoms and induce and maintain remission. Routine measures include updating the products prescribing information with a warning and description of the event, and inclusion in the. Simponi can lower your ability to fight infections. Remicade infliximab can cause serious side effects such as lowering your ability to fight infections. Entyvio for injection is supplied in sterile, 20 ml, singledose glass vials, containing 300 mg of vedolizumab as a white to offwhite lyophilized cake. You can obtain a printable pdf of the full prescribing information and the. The enbreletanercept instructions for use insert for each presentation contains more detailed instructions on injection site selection and the preparation of enbrel. Learn about the cidp ice study and treatment options with jon katz, md, neurology. Medication guide simponi simponee golimumab injection, for subcutaneous use what is the most important information i should know about simponi. Official consumer website for remicade infliximab remicade. Rheumatoid arthritis pharmacologic treatment guidelines.
Once the overwrap package is opened, use within 24 hours see storage and handling 16. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Infusionrelated reactions and hypersensitivity reactions including anaphylaxis have occurred. Taltz ixekizumab injection, for subcutaneous use initial u. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tnf blockers, of which simponi aria. Physicians should alert patients to the presence of the patient package insert, provide this. Renflexis infliximababda official patient web site. The active ingredient in remicade is infliximab, a tumor necrosis factoralpha tnfalpha inhibitor.
Renflexis infliximababda is biosimilar to remicade infliximab. Lcysteine hydrochloride hydrate 10 mg, sodium bisul. Highlights of prescribing information these highlights do not include all the information needed to use. Each bag contains the following inactive ingredients. Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial. People with certain diseases have too much tnfalpha that can cause the immune system to attack normal healthy parts of the body. See full prescribing information including boxed warning on serious infections. Refer todoxorubicin prescribing information for dosing, and dose modifications. Remicade is indicated for the reduction of signs and symptoms and. Highlights of prescribing information for intravenous.
Simponi can lower the ability of your immune system to fight infections. If reactivation occurs, stop remicade and begin most common adverse reactions 10% infections e. During remicade treatment, other concomitant therapies, e. Highlights of prescribing information these highlights do not include all the information needed to use remicade. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for remicade infliximab. Pdf on august 24, 1998, remicade infliximab, the first tumor necrosis factor. Each vial of the remicade product contains infliximab 100 mg. This medication guide does not take the place of talking with your doctor about your medical condition.
Approximately half the cases were lymphomas, including hodgkins and nonhodgkins lymphoma. Serious infections and malignancy see full prescribing information for complete boxed warning. Renflexis is a prescription medication used to treat. Menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by. If these medicines or treatments do not work well enough, you will be given remicade to reduce the signs and symptoms of your disease.
Rheumatoid arthritis adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate. Take advantage of the financial and resource support for your patients and office staff. Inflectra infliximabdyyb for injection safety info. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively. Highlights of prescribing information these highlights do not. Inflectra infliximabdyyb for injection, for intravenous use.