Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 120mg/vial
- 400mg/vial
SC solution
- 200mg/mL single-dose, prefilled syringe or autoinjector
Systemic Lupus Erythematosus
Indicated for active, autoantibody-positive systemic lupus erythematosus (SLE) in patients who are receiving standard therapy
IV
SC
- 200 mg SC qWeek
- SC dosing is NOT weight-based
- If transitioning from IV to SC, administer first SC dose 1-4 weeks after the last IV dose
Lupus Nephritis
Indicated for active lupus nephritis in patients who are receiving standard therapy
IV
SC
- Initial: 400-mg dose (two 200-mg injections) SC qWeek x 4 doses, THEN
- Maintenance: 200 mg SC qWeek thereafter
-
Transitioning from IV to SC dosing
- May transition from IV to SC any time after completing the first 2 IV doses
- If transitioning, administer first SC dose of 200 mg 1-2 weeks after the last IV dose
Dosage Modifications
Renal or hepatic impairment: No dosage adjustment recommended for any degree of impairment
Dosing Considerations
Limitations of use
- Not evaluated in patients with severe active central nervous system lupus
- Not studied in combination with other biologics; use not recommended in these situations
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 120mg/vial
- 400mg/vial
SC solution
- 200mg/mL single-dose, prefilled syringe or autoinjector
Systemic Lupus Erythematosus
Indicated for treatment of patients aged ≥5 years with active, autoantibody-positive, SLE who are receiving standard therapy
<5 years: Safety and efficacy not established
≥5 years
- SC: Safety and efficacy not established in patients <18 years
-
IV
- Initial: 10 mg/kg IV q2Weeks x 3 doses, THEN
- Maintenance: 10 mg/kg IV q4Weeks
Lupus Nephritis
Indicated for active lupus nephritis in patients aged ≥5 years who are receiving standard therapy
<5 years: Safety and efficacy not established
≥5 years
- SC: Safety and efficacy not established in patients <18 years
-
IV
- Initial: 10 mg/kg IV q2Weeks x 3 doses, THEN
- Maintenance: 10 mg/kg IV q4Weeks
Dosage Modifications
Renal or hepatic impairment: No dosage adjustment recommended for any degree of impairment
Dosing Considerations
Limitations of use
- Not evaluated in patients with severe active central nervous system lupus
- Not studied in combination with other biologics; use not recommended in these situations
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (34)
- anthrax vaccine adsorbed
belimumab decreases effects of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- BCG vaccine live
belimumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- diphtheria & tetanus toxoids
belimumab decreases effects of diphtheria & tetanus toxoids by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
belimumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
belimumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- hepatitis A vaccine inactivated
belimumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- hepatitis a/b vaccine
belimumab decreases effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- hepatitis b vaccine
belimumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- influenza A (H5N1) vaccine
belimumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- influenza virus vaccine (H5N1), adjuvanted
belimumab decreases effects of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- influenza virus vaccine quadrivalent, cell-cultured
belimumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- influenza virus vaccine quadrivalent, intranasal
belimumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- Japanese encephalitis virus vaccine
belimumab decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- measles (rubeola) vaccine
belimumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- measles mumps and rubella vaccine, live
belimumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- measles, mumps, rubella and varicella vaccine, live
belimumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
belimumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- pneumococcal vaccine 13-valent
belimumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- pneumococcal vaccine heptavalent
belimumab decreases effects of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- pneumococcal vaccine polyvalent
belimumab decreases effects of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- rabies vaccine
belimumab decreases effects of rabies vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- rabies vaccine chick embryo cell derived
belimumab decreases effects of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- rotavirus oral vaccine, live
belimumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- rubella vaccine
belimumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- smallpox (vaccinia) vaccine, live
belimumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- tetanus toxoid adsorbed or fluid
belimumab decreases effects of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- travelers diarrhea and cholera vaccine inactivated
belimumab decreases effects of travelers diarrhea and cholera vaccine inactivated by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- tuberculin purified protein derivative
belimumab decreases effects of tuberculin purified protein derivative by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- typhoid polysaccharide vaccine
belimumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- typhoid vaccine live
belimumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- upadacitinib
belimumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- varicella virus vaccine live
belimumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- yellow fever vaccine
belimumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
- zoster vaccine live
belimumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.
Serious - Use Alternative (5)
- adenovirus types 4 and 7 live, oral
belimumab decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- human papillomavirus vaccine, nonavalent
belimumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- human papillomavirus vaccine, quadrivalent
belimumab decreases effects of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- influenza virus vaccine quadrivalent, adjuvanted
belimumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
belimumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
Monitor Closely (17)
- belatacept
belatacept and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- denosumab
belimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- fingolimod
belimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
hydroxyurea, belimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.
- ifosfamide
ifosfamide, belimumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- influenza virus vaccine quadrivalent, recombinant
belimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- influenza virus vaccine trivalent, recombinant
belimumab decreases effects of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- lomustine
lomustine and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- meningococcal group B vaccine
belimumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, belimumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
belimumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oxaliplatin
oxaliplatin and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.
- poliovirus vaccine inactivated
belimumab decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- sipuleucel-T
belimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, belimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, belimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- zoster vaccine recombinant
belimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
Listed adverse reactions of belimumab PLUS standard therapy
>10%
SC
- Nausea (15%)
- Diarrhea (12%)
1-10%
IV
- Pyrexia (10%)
- Nasopharyngitis (9%)
- Bronchitis (9%)
- Insomnia (7%)
- Pain in extremity (6%)
- Depression (5%)
- Migraine (5%)
- Pharyngitis (5%)
- Cystitis (4%)
- Leukopenia (4%)
- Gastroenteritis viral (3%)
SC
- Serious infections (4.1%)
- Depression-related events (2.7%)
- Suicidal ideation (1.3%)
<1%
SC
- Fatal infections (0.5%)
- Serious psychiatric events (0.2%)
Postmarketing Reports
Fatal anaphylaxis
Warnings
Contraindications
Anaphylaxis to belimumab
Cautions
Serious and sometimes fatal infections 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
Impact on development of malignancies is unknown; as with other immunomodulating agents, mechanism of action of belimumab could increase the risk for developing malignancies; consider individual benefit-risk in patients with known risk factors for development or reoccurrence of malignancy prior to prescribing this medication; in patients who develop malignancies, consider risk and benefit of continued treatment
Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, reported in patients with SLE receiving immunosuppressants; risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function; consider 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, reported; events generally occurred within hours of 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) 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 patient develops a reaction; monitor during and for an appropriate period of time after infusion
- Healthcare providers should be aware of 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 risk of depression and suicide considering the patient’s medical history and current psychiatric status
- Continue to monitor during treatment
- Instruct patients to contact healthcare provider if new or worsening depression arises, suicidal thoughts or behavior, or other mood changes; assess risk and benefit of continued therapy for patients who develop such symptoms
- Consider 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
- Coadministration not recommended
- Not studied in combination with other biologic therapies (eg, B-cell targeted therapies)
- Concomitant use with rituximab increased incidence of serious infections and post-injection systemic reactions observed
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to this therapy during pregnancy; healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inhibits the biological activity of B-lymphocyte stimulator (BLyS); BLyS is a naturally occurring protein required for survival and development of B-lymphocyte cells into mature plasma B cells that produce antibodies
In autoimmune diseases, elevated BLyS levels are thought to contribute to production of autoantibodies
Belimumab specifically recognizes and binds to BLyS, inhibits BLyS’s stimulation of B-cell development, and finally, restores the potential for autoantibody-producing B cells to undergo the normal process of apoptosis (programmed cell death)
Absorption
Peak plasma concentration: 313 mcg/mL (IV); 108 mcg/mL (SC)
AUC: 3,083 days•mcg/mL (IV); 726 days•mcg/mL (SC)
Distribution
Vd (steady-state): 5 L
Half-life, distribution: 1.8 days (IV); 1.1 days (SC)
Elimination
Half-life, terminal: 19.4 days (IV); 18.3 days (SC)
Clearance: 215 mL/day (IV); 204 mL/day (SC)
Administration
IV Compatibilities
0.9% NaCl
0.45% NaCl
Lactated Ringer solution
IV Incompatibilities
Dextrose solutions
IV Preparation
Lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted using aseptic technique
Remove vial from refrigerator; let stand for 10-15 minutes to reach room temperature
Reconstitution
- Remove vial from refrigerator; allow vial to reach room temperature for 10-15 min
- Reconstitute with 1.5 mL (120-mg vial) and 4.8 mL (400-mg vial) of sterile water for injection to final concentration of 80 mg/mL
- Direct stream of sterile water toward side of vial to minimize foaming
- DO NOT SHAKE; gently swirl vial for 60 seconds every 5 minutes until powder is dissolved
- Reconstitution is typically complete within 10-15 minutes, but may take up to 30 minutes
- Note: If mechanical reconstitution device is used, it should not exceed 500 rpm and vial swirled for no longer than 30 minutes
- Once reconstituted, solution should be opalescent and colorless to pale yellow, and without particles; small air bubbles are expected and acceptable
Dilution
- Dilute reconstituted solution in 250-mL infusion bag (ie, 0.9% NaCl, 0.45% NaCl, LR) OR in 100-mL infusion bag if patient weighs <40 kg
- Withdraw and discard volume equal to volume of the reconstituted solution required for dose
- Add required volume of reconstituted solution to infusion bag/bottle (final concentration should not exceed 4 mg/mL)
- Gently invert bag/bottle to mix the solution
- Visually inspect for particulate matter and discoloration before administration, whenever solution and container permits
- Discard any unused portion
- Total time from reconstitution to completion of infusion should not exceed 8 hours
IV Administration
Administer diluted solution IV over 1 hour
Administer by health care providers prepared to manage anaphylaxis
Do not infuse concomitantly in same IV line with other drugs
Consider administering premedication (ie, antihistamines, corticosteroids) for prophylaxis against infusion reactions and hypersensitivity
SC Preparation
Instruct patient to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the SC injection; do not warm drug in any other way
Visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration; solution should be clear to opalescent and colorless to pale yellow
Do not use if the product exhibits discoloration or particulate matter
Instruct the patient not to use autoinjector or prefilled syringe if dropped on a hard surface
SC Administration
SC route only for adults aged ≥18 years
Administer SC once weekly, preferably on the same day each week
Administer SC in abdomen or thigh
When injecting in the same body region, advise to use a different injection site for each injection; never give injections into areas where the skin is tender, bruised, red, or hard
When a 400-mg dose is administered at same site, it is recommended that the 2 individual 200-mg injections be administered at least 5 cm (~2 inches) apart
Missed dose
- Administer missed dose as soon as the patient remembers
- Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly schedule from the day that the missed dose was administered
- Not recommended to administer 2 doses on the same day
Storage
Unopened IV vials
- Store refrigerated 2-8ºC (36-46ºF); do not freeze
- Store vials in original carton and protect from light until use
- Avoid exposure to heat
Reconstituted IV vials
- If not used immediately, may be stored refrigerated 2-8ºC (36-46ºF)
- For single use only; discard any unused portion
Diluted IV solution
- Refrigerate at 2-8ºC (36-46ºF) or at room temperature
- Total time from reconstitution to completion of infusion should not exceed 8 hours
SC prefilled syringes or autoinjector
-
Refrigerated
- Refrigerate prefilled syringe or autoinjectors at 2-8°C (36-46°F)
- Keep product in the original carton to protect from light until the time of use
- Do not freeze, shake, or expose to heat
-
Nonrefrigerated
- May be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hr in the original container
- Do not use and do not place back in refrigerator if left out for >12 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Benlysta subcutaneous - | 200 mg/mL solution |  | |
| Benlysta subcutaneous - | 200 mg/mL syringe |  | |
| Benlysta subcutaneous - | 200 mg/mL syringe |  | |
| Benlysta intravenous - | 120 mg vial |  | |
| Benlysta intravenous - | 400 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
belimumab intravenous
BELIMUMAB - INJECTION
(be-LIM-ue-mab)
COMMON BRAND NAME(S): Benlysta
USES: This medication is used with other medications to treat certain types of lupus. Belimumab belongs to a class of drugs known as monoclonal antibodies. It works by decreasing the effect of a certain protein that is increased in people with active lupus. This may help decrease some of the symptoms of lupus.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using belimumab and each time you get a treatment. Discuss the risks and benefits of belimumab treatment. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. It should be injected slowly over 1 hour. The first 3 doses are given every 2 weeks. After the third dose, it is usually given every 4 weeks, or as directed by your doctor. The dosage is based on your weight.Your doctor may prescribe other medications for you to take before the start of your treatment to help prevent serious side effects.This medication may cause very serious reactions during or after treatment. These reactions occur more often during the first and second treatments. Your doctor will monitor you closely. If you have a reaction, your treatment will be temporarily stopped. Tell your doctor or nurse right away if any of these effects occur: headache, slow heartbeat, muscle pain, dizziness/fainting, nausea, or rash/itching.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also How to Use section.Nausea, diarrhea, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new/worsening depression, thoughts of suicide), signs of cancer (such as fever, night sweats, unusual tiredness, unexplained weight loss, swollen glands, unusual lumps/growths).This medication can lower your body's ability to fight an infection. You may be more likely to get serious infections such as pneumonia, urinary tract infection, and skin infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop signs of a serious infection while using this drug, such as: fever, chills, sore throat, cough, pain or burning with urination, urinating often, bloody diarrhea, coughing up mucus.Belimumab may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you develop any signs of PML, including: confusion, memory loss, loss of balance, difficulty talking/walking, vision changes.Get medical help right away if you have any serious side effects, including: heart problems (such as chest/jaw/left arm pain, shortness of breath, unusual sweating, dizziness).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.
PRECAUTIONS: Before using belimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: infections (current infections, infections that return), mental/mood problems (such as depression, thoughts of suicide), cancer.Belimumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using belimumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits, and reliable forms of birth control with your doctor. The manufacturer recommends the use of reliable forms of birth control during treatment and for at least 4 months after your last treatment.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
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.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
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.
NOTES: Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
