BELIMUMAB PACKAGE INSERT PDF

Receipt of belimumab also led to reductions in IgG and anti-dsDNA and to increases in complement C3 and C4 as early as week 8 and were sustained through week Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or belimummab temperature. These findings were reversible within 3 to 12 months after the drug was discontinued. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Serious infusion reactions excluding hypersensitivity reactions were reported in 0. Therefore, belimumab use is not recommended in combination with biologic therapies. No data are available on the secondary transmission of infection from persons receiving live lackage.

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Patients receiving immunosuppressants are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections.

Caution should be exercised when considering their use in patients with severe or chronic infections. It is recommended to interrupt therapy in patients who develop a new infection while undergoing treatment and to monitor these patients closely for any sign or symptom indicative of infection.

Applies to: Immunodeficiency Immunosuppressive agents may increase the risk of progressive multifocal leukoencephalopathy PML. Certain agents are contraindicated in patients who have or have had PML.

Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with these agents. Healthcare professionals should monitor patients for any new sign or symptom suggestive of PML. Withhold therapy dosing immediately and perform an appropriate diagnostic evaluation at the first sign or symptom suggestive of PML. Applies to: Depression Psychiatric events have been reported with the use of belimumab.

Caution is recommended when prescribing this agent to patients with serious depression or suicidal behavior, history of depression, or other serious psychiatric disorders. Patients receiving belimumab should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes while on belimumab.

Applies to: Vaccination Live vaccines should not be given for 30 days before or concurrently with belimumab as clinical safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving belimumab or the effect of belimumab on new immunizations.

Because of its mechanism of action, belimumab may interfere with the response to immunizations. Benlysta belimumab drug interactions There are 99 drug interactions with Benlysta belimumab More about Benlysta belimumab.

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BELIMUMAB PACKAGE INSERT PDF

More What is Benlysta? Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Benlysta is used together with other lupus medicines to treat active systemic lupus erythematosus SLE. Benlysta helps decrease disease activity more than when the other medicines are used alone.

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Tremelimumab

Patients receiving immunosuppressants are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections. Caution should be exercised when considering their use in patients with severe or chronic infections. It is recommended to interrupt therapy in patients who develop a new infection while undergoing treatment and to monitor these patients closely for any sign or symptom indicative of infection. Applies to: Immunodeficiency Immunosuppressive agents may increase the risk of progressive multifocal leukoencephalopathy PML. Certain agents are contraindicated in patients who have or have had PML. Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with these agents.

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Benlysta (belimumab) Disease Interactions

In the adult SC clinical trial, death occurred in 0. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection. Hypersensitivity Reactions including Anaphylaxis : Acute hypersensitivity reactions, including anaphylaxis eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions eg, rash, nausea, fatigue, myalgia, headache, and facial edema typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Healthcare providers HCPs should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction.

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Drug Approval Package: Benlysta (belimumab)

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