Saphnelo, anifrolumab-fnia (anifrolumab) dosing, indications, interactions, adverse effects, and more (original) (raw)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

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

Hepatic impairment

Dosing Considerations

Limitation of use

Safety and efficacy not established

Interactions

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No Interactions Found

Interactions Found

Contraindicated

Serious

Significant - Monitor Closely

Minor

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Contraindicated (0)

Serious (17)

Monitor Closely (1)

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

Hypersensitivity reactions

Malignancy

Other biologic therapies

Drug interaction overview

Live or live attenuated immunizations

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

Clinical considerations

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

Diluted solution

Images

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Patient Handout

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.