Belimumab

Belimumab is used as a prescription medication for treating systemic lupus erythematosus or lupus nephritis.

• Belimumab is available under the following different brand names: Benlysta

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 120mg/vial
• 400mg/vial

SC solution

• 200mg/mL single-dose, prefilled syringe or autoinjector

Systemic Lupus Erythematosus

Adult dosage

IV

• Initial: 10 mg/kg IV every 2 weeks x 3 doses, THEN  
• Maintenance: 10 mg/kg IV every 4 weeks

SC

• 200 mg SC every week 
• SC dosing is NOT weight-based
• If transitioning from IV to SC, administer the first SC dose 1-4 weeks after the last IV dose

Pediatric dosage

• Children below 5 years: Safety and efficacy not established
• Children above 5 years

SC 

• Safety and efficacy not established in patients <18 years

IV

• Initial: 10 mg/kg IV every 2 weeks x 3 doses, THEN
• Maintenance: 10 mg/kg IV every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Belimumab include:

• nausea,
• diarrhea,
• fever,
• sore throat,
• runny or stuffy nose,
• cough,
• pain, itching, redness, or swelling at the injection site,
• pain in the arms or legs,
• headache,
• depressed mood, and
• sleep problems (insomnia).

Serious side effects of the Belimumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• anxiety,
• lightheadedness,
• nausea,
• itching,
• severe headache,
• skin redness and swelling,
• fever,
• chills,
• cough with mucus,
• pain or burning while urinating,
• urinating more than usual,
• bloody diarrhea,
• new or worsening depression,
• mood or behavior changes,
• trouble sleeping,
• risk-taking behavior,
• thoughts about hurting oneself or others,
• wheezing,
• chest tightness,
• trouble breathing,
• chest pain or pressure,
• pain spreading to the jaw or shoulder, and
• sweating

Rare side effects of the Belimumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Belimumab has severe interactions with at least 33 other drugs.
• Belimumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • human papillomavirus vaccine, nonavalent
  • human papillomavirus vaccine, quadrivalent
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
• Belimumab has moderate interactions with the following drugs:
  • belatacept
  • denosumab
  • fingolimod
  • hydroxyurea
  • ifosfamide
  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, recombinant
  • lomustine
  • meningococcal group B vaccine
  • ofatumumab SC
  • olaparib
  • oxaliplatin
  • poliovirus vaccine inactivated
  • sipuleucel-T
  • trastuzumab
  • trastuzumab deruxtecan
  • zoster vaccine recombinant
• Belimumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Anaphylaxis to belimumab

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Belimumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Belimumab?”

Cautions

• Serious and sometimes fatal infections are reported in patients receiving immunosuppressive agents; consider risk and benefit before initiating treatment in patients with severe or chronic infections; consider interrupting therapy in patients who develop a new infection during therapy and monitor patients closely
• The impact on the development of malignancies is unknown; as with other immunomodulating agents, the mechanism of action of belimumab could increase the risk of developing malignancies
• Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, are reported in patients with SLE receiving immunosuppressants; risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function; consider the diagnosis of PML in any patient presenting with new-onset or deteriorating neurological signs and symptoms and consult with a neurologist or other appropriate specialist as clinically indicated; in patients with confirmed PML, consider stopping therapy
• Hypersensitivity reactions
  • Acute hypersensitivity reactions, including anaphylaxis and death, were reported; events generally occurred within hours of the infusion; however, they may occur later; non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema reported and typically occurred up to a week following the most recent infusion
  • Hypersensitivity, including serious reactions, has occurred in patients who have previously tolerated infusions of the drug; limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk
  • Therapy should be administered by healthcare providers prepared to manage anaphylaxis; in the event of a serious reaction, discontinue treatment immediately and administer appropriate medical therapy; monitor patients during infusion and for an appropriate period of time after intravenous administration of the drug
  • Consider administering premedication as prophylaxis prior to intravenous dosing; Inform patients receiving the drug of the signs and symptoms of hypersensitivity reactions and instruct them to seek immediate medical care should a reaction occur
• Infusion reactions
  • Serious infusion reactions (excluding hypersensitivity reactions) were reported, including bradycardia, myalgia, headache, rash, urticaria, and hypotension; most common reactions included headache, nausea, and skin reactions; consider administering premedication as prophylaxis prior to intravenous dosing
  • For intravenous use, therapy should be administered by healthcare providers prepared to manage infusion reactions; infusion rate may be slowed or interrupted if a patient develops a reaction; monitor during and for an appropriate period of time after infusion
  • Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely; instruct patients to seek immediate medical care should a reaction occur
• Depression and suicidality
  • In clinical trials, psychiatric events were associated with IV administration in SLE patients
  • Before treatment, assess the risk of depression and suicide considering the patient’s medical history and current psychiatric status
  • Continue to monitor during treatment
  • Instruct patients to contact a healthcare provider if new or worsening depression arises, suicidal thoughts or behavior, or other mood changes; assess the risk and benefit of continued therapy for patients who develop such symptoms
  • Consider the risk and benefit of continued treatment for patients who develop symptoms of depression or suicidality
• Drug interaction overview
  • Immunizations
    • Do not administer live vaccines 30 days before or concurrently with belimumab
    • May decrease response to immunizations
  • Other biologic therapies
    • Not studied in combination with other biologic therapies (eg, B-cell targeted therapies) and therefore not recommended

Pregnancy and Lactation

• Healthcare professionals are encouraged to register patients by calling the pregnancy registry: at 1- (877) 681-6296
• Data are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage
• There are risks to the mother and fetus associated with SLE, including worsening of the underlying disease, premature birth, spontaneous abortion, and intrauterine growth restriction
• Clinical considerations
  • Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia
  • Passage of maternal antiphospholipid antibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block
  • Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant
  • Use during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus
• Contraception
  • Following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment
• Lactation
  • Passage of maternal antiphospholipid antibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block
  • Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant
  • Use during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus
  • Because maternal antibodies are excreted in human breast milk, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of breastfeeding to the infant and the importance of the drug to the mother