Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 300mg/2mL (single-dose vial)
Systemic Lupus Erythematosus
Indicated for moderate-to-severe systemic lupus erythematosus (SLE) in adults who are receiving standard therapy
300 mg IV q4Weeks
Dosage Modifications
Renal impairment
- Mild-to-moderate (30-89 mL/min/1.73 m2): Based on population pharmacokinetic analyses, drug clearance decreases in eGFR
- Severe (<30 mL/min/1.73 m2) or end-stage renal disease: No patients in analyses
- Anifrolumab is not cleared renally
Hepatic impairment
- Not studied
- IgG1 monoclonal antibodies predominantly eliminated via catabolism and are not expected to undergo hepatic metabolism; changes in hepatic function are not expected to influence clearance
- Based on population pharmacokinetic analyses, baseline hepatic function biomarkers (ALT and AST ≤2x ULN, and total bilirubin) had no clinically relevant effect on clearance
Dosing Considerations
Limitation of use
- Not evaluated in patients with severe active lupus nephritis or severe active CNS lupus; use not recommended in these situations
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (20)
- adenovirus types 4 and 7 live, oral
anifrolumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- BCG vaccine live
anifrolumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- cholera vaccine
anifrolumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- dengue vaccine
anifrolumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- Ebola Zaire vaccine
anifrolumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- influenza virus vaccine quadrivalent, intranasal
anifrolumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- measles (rubeola) vaccine
anifrolumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- measles mumps and rubella vaccine, live
anifrolumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- measles, mumps, rubella and varicella vaccine, live
anifrolumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- poliovirus vaccine live oral trivalent
anifrolumab decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- rotavirus oral vaccine, live
anifrolumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- rubella vaccine
anifrolumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating
anifrolumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- smallpox (vaccinia) vaccine, attenuated
anifrolumab decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- smallpox (vaccinia) vaccine, live
anifrolumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- typhoid polysaccharide vaccine
anifrolumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- typhoid vaccine live
anifrolumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- varicella virus vaccine live
anifrolumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- yellow fever vaccine
anifrolumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- zoster vaccine live
anifrolumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
Monitor Closely (1)
- ublituximab
ublituximab and anifrolumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Upper respiratory tract infection (34%)
Bronchitis (11%)
1-10%
Infusion-related reactions (9.4%)
Herpes zoster (6.1%)
Cough (5%)
Respiratory tract infection (3.3%)
Hypersensitivity (2.8%)
Malignant neoplasm (including nonmelanoma skin cancers) (1.3%)
<1%
Malignancies (excluding nonmelanoma skin cancers (0.7%)
Warnings
Contraindications
History of anaphylaxis associated with anifrolumab
Cautions
Update immunizations, according to current immunization guidelines, before initiating therapy
Serious infections
- Serious and sometimes fatal infectious occurred
- May increase risk of respiratory tract infections and herpes zoster
- Avoid initiating during active infection until infection resolves or is adequately treated
- If signs or systems of infection occur, instruct patients to seek medical advice
- Consider the benefit-risk if using in patients with severe or chronic infections
- If an infection develops, or is not responding to standard anti-infective therapy, closely monitor patient and consider interrupting therapy until infection resolves
Hypersensitivity reactions
- Hypersensitivity reactions, including anaphylaxis and angioedema, reported
- Other hypersensitivity reactions and infusion-related reactions occurred following administration
- Consider premedication before infusion for patients with history of these reactions
- Prepare to manage hypersensitivity reactions and infusion-related reactions
- If such reactions occur, immediately interrupt administration and initiate appropriate therapy
Malignancy
- Use of immunosuppressants may increase risk of malignancies
- Unknown if anifrolumab may also increases such risk
- Consider the benefit-risk in patients with known risk factors for developing or recurring malignancies before prescribing therapy
- In patients who develop malignancies, consider the benefit-risk of continued treatment
Other biologic therapies
- Not recommended
- Not studied in combination with other biologic therapies, including B-cell–targeted therapies
Drug interaction overview
Live or live attenuated immunizations
- Avoid use
- Update immunizations, according to current immunization guidelines, before initiating
Pregnancy & Lactation
Pregnancy
Limited human data with use in pregnant females are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome
Pregnancy exposure registry
- Monitor pregnancy outcomes in females exposed to anifrolumab during pregnancy
- For more information, contact AstraZeneca at 1-877-693- 9268
Clinical considerations
- Monoclonal antibodies are known to cross the placenta as pregnancy progresses; therefore, anifrolumab exposure to fetus may be greater during third trimester of pregnancy
- Pregnant females with SLE are at increased risk of adverse pregnancy outcomes (eg, worsening of underlying disease, premature birth, miscarriage, intrauterine growth restriction)
- Maternal lupus nephritis may increase risk of hypertension and preeclampsia/eclampsia
- Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus a congenital heart block
Lactation
No data are available regarding presence of drug in human milk, effects on breastfed children, or effects on milk production
Detected in milk of treated female cynomolgus monkeys
Maternal IgG is known to be present in human milk
If drug is transferred into human milk, effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to therapy are unknown
Consider benefits of breastfeeding along with mother’s clinical need and any potential adverse effects on the breastfed child from therapy or from underlying maternal condition
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
IgG1 monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor; binding inhibits type 1 IFN signaling, thereby blocking biologic activity of type 1 IFNs
Also, induces internalization of type 1 IFN receptor, which reduces levels of cell surface available for receptor assembly
Blockade of receptor-mediated type 1 IFN signaling inhibits IFN-responsive gene expression as well as downstream inflammatory and immunological processes
Inhibition of type 1 IFN blocks plasma cell differentiation and normalizes peripheral T-cell subsets
Absorption
Steady-state was reached by Day 85
Accumulation ratio: 1.36 (Cmax); 2.49 (Ctrough)
Distribution
Vd: 6.23 L
Metabolism
IgG1 monoclonal antibodies not expected to undergo hepatic metabolism
Elimination
Estimated systemic clearance (CL): 0.193 L/day
Administration
IV Incompatibilities
Do not coadminister other medicinal products through same infusion line
IV Compatibilities
0.9% NaCl
IV Preparation
Visually inspect vial for particulate matter and discoloration; solution is clear to opalescent, colorless to slightly yellow; discard if solution is cloudy, discolored, or visible particles observed
Do NOT shake
Withdraw 2 mL from 100-mL 0.9% NaCl infusion bag and discard solution
Withdraw 2 mL of drug from vial and add to infusion bag; gently invert bag to mix; do NOT shake
Each vial is intended for single dose only; discard any unused portion remaining in vial
Administer solution immediately after preparation
IV Administration
If diluted solution was refrigerated, allow it to reach room temperature before administration
Infuse over 30 min through an infusion line containing a sterile, low-protein–binding 0.2- or 0.22-micron inline filter
Flush infusion set with 25 mL of 0.9% NaCl to ensure all the drug has been administered
Dispose of any unused medicinal product or waste material in accordance with local requirements
Missed dose: Administer as soon as possible; maintain a minimum interval of 14 days between infusions
Storage
Protect from light
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton; do NOT freeze
Diluted solution
- If not administered immediately, store at room temperature (15-25ºC [59-77ºF]) for up to 4 hr OR
- Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr; do NOT freeze
Images
Formulary
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