Saphnelo (anifrolumab-fnia)
Immunosuppressive - Interferon Inhibitor, Monoclonal Ab Intravenous Vial (Ml); Subcutaneous Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Anifrolumab-fnia, a type I interferon (IFN) receptor antagonist, is an immunosuppressive agent.
Anifrolumab-fnia, a human immunoglobulin (Ig)G1kappa monoclonal antibody produced in mouse myeloma cells by recombinant DNA technology, is an antagonist of the type I interferon receptor (IFNAR) that binds to subunit 1 with high specificity and affinity. This antagonistic activity reduces the levels of surface IFNAR1 available for receptor assembly and prevents type I interferon (IFN) signaling, thereby blocking the activity of type I IFNs involved in responsive gene expression and downstream inflammatory and immunological processes. Blockade of type 1IFN also prevents plasma cell differentiation and normalizes subsets of peripheral T-cells.
Type I IFN inducible genes are involved in the pathogenesis of systemic lupus erythematosus (SLE) and are elevated in approximately 60-80% of adult patients with active disease.
Anifrolumab exhibits non-linear pharmacokinetics in healthy patients over a dosage range of 100-1000 mg, and more than dose-proportional increases in exposure as measured by the area under the concentration-time curve (AUC). Following a 300 mg IV infusion every 4 weeks, steady-state is attained by day 85. Anifrolumab exhibits IFNAR1-mediated drug clearance that is non-linear.
Following withdrawal of anifrolumab infusions after a 52-week treatment period, plasma levels of type I inducible genes return to baselineafter 8-12 weeks. No clinically meaningful differences in systemic clearance of anifrolumab have been found based on age, race, ethnicity, region, gender, IFN status, or body weight.
USES: This medication is used to treat a certain immune system problem (lupus). Anifrolumab belongs to a class of drugs known as monoclonal antibodies.
Generic name: anifrolumab-fnia
Pronunciation: (AN-i-FROL-ue-mab)
Drug class: Immunosuppressive - Interferon Inhibitor, Monoclonal Ab
Therapeutic class: Immunosuppressive Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Saphnelo
Indications
The following indications are listed for Saphnelo:
- Systemic Lupus Erythematosus
Also known as: Disseminated Lupus Erythematosus, Lupus Erythematosus Syndrome.
Dosing
No dosing information is available for this tab.
Anifrolumab-fnia is available as an injection concentrate that must be diluted prior to administration.
Anifrolumab injection is preservative-free. Discard any unused portion left in the single-use vial after preparation.
To ensure full delivery of the anifrolumab dose, flush the entire infusion line with 25 mL of 0.9% sodium chloride injection at the end of the infusion. Do not administer other medications concomitantly via the same infusion line. Interrupt the infusion of anifrolumab if the patient develops any signs of adverse reactions, including infusion or hypersensitivity reactions.
If a planned infusion is missed, administer the infusion as soon as possible. Maintain a minimum interval of 14 days between infusions.
Store unopened vials of anifrolumab-fnia injection concentrate between 2-8degreesC in the original carton to protect from light; do not freeze or shake.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Saphnelo 300 Mg/2 Ml Vial | Maintenance | Infuse 300 mg over 30 minute(s) by intravenous route every 4 weeks. |
| Saphnelo 120 Mg/0.8 Ml Syringe | Maintenance | Inject 120 mg by subcutaneous route once weekly. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been conducted with anifrolumab.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Selected Immunosuppressive Agents/Live Vaccines; Live Bcg
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Anifrolumab/Biologic Therapies
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Concurrent use of anifrolumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1)
CLINICAL EFFECTS: Concurrent use of anifrolumab with other biologic therapies may increase the risk of serious infections.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The concurrent use of anifrolumab with other biologic therapies is not recommended.(1)
DISCUSSION: The combination of anifrolumab with other biologic therapies has not been studied and is not recommended.(1)
Igg Antibodies And Derivatives/Efgartigimod-Alfa
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)
Igg Antibodies And Derivatives/Nipocalimab-Aahu
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)
DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Igg Antibodies And Derivatives/Rozanolixizumab-Noli
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)
CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)
DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)
Contraindications
History of anaphylactic reaction to anifrolumab.
There are no contraindication contraindications for this drug.
- Infection
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions reported in 5% or more of patients receiving anifrolumab in clinical trials include nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough.
More Frequent
- Herpes zoster
Less Frequent
- Hypersensitivity drug reaction
- Infection
- Injection site sequelae
Rare or Very Rare
- Anaphylaxis
- Angioedema
- Malignancy
- Pneumonia
More Frequent
- Bronchitis
- Cough
- Pharyngitis
- Upper respiratory infection
Less Frequent
- Arthralgia
- Back pain
- Chest pain
- Diarrhea
- Dizziness
- Fatigue
- Headache disorder
- Nausea
- Pain in extremities
- Peripheral edema
- Sinusitis
- Urinary tract infection
- Vomiting
Rare or Very Rare
- Blurred vision
- Depression
- Diabetes mellitus
- General weakness
- Hemorrhoids
- Hyperglycemia
- Hypertension
Precautions
No enhanced messaging available.
Safety and efficacy of anifrolumab in pediatric patients less than 18 years of age are not established.
Limited human data are available to inform the drug-associated risk of anifrolumab use in pregnancy. Animal data indicate no evidence of embryo or fetal malformations with exposures approximately 28 times the exposure at the maximum recommended human dose (MRHD) on an area under the curve (AUC) basis. Since monoclonal immunoglobulin (Ig)G antibodies such as anifrolumab undergo active transport across the placenta as the pregnancy progressives, fetal exposure to anifrolumab is considered greatest in the third trimester. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to anifrolumab. For more information, contact AstraZeneca at 1-877-693-9268.
It is not known whether anifrolumab is distributed into human milk; however, anifrolumab has been detected in the milk of female monkeys in animal studies. Human immune globulin G (IgG) is known to be present in human milk. The effects of the drug on the breast-fed infant or on milk production are not known. Consider the benefits of breast-feeding along with the potential for adverse effects from anifrolumab exposure to the breast-fed infant and the mother's clinical need for anifrolumab.
The manufacturer makes no specific dosage recommendations for geriatric patients.
In clinical trials, 664 patients with systemic lupus erythematosus (SLE) were exposed to anifrolumab, with 3% (n=20) aged 65 years or older. The number of patients 65 years of age or older was insufficient to determine whether they respond differently from younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Systemic lupus erythematosus | ||
| M32 | ICD10CM | Systemic lupus erythematosus (SLe) |
| M32.0 | ICD10CM | Drug-induced systemic lupus erythematosus |
| M32.1 | ICD10CM | Systemic lupus erythematosus with organ or system involvement |
| M32.10 | ICD10CM | Systemic lupus erythematosus, organ or system involvement unspecified |
| M32.11 | ICD10CM | Endocarditis in systemic lupus erythematosus |
| M32.12 | ICD10CM | Pericarditis in systemic lupus erythematosus |
| M32.13 | ICD10CM | Lung involvement in systemic lupus erythematosus |
| M32.14 | ICD10CM | Glomerular disease in systemic lupus erythematosus |
| M32.15 | ICD10CM | Tubulo-interstitial nephropathy in systemic lupus erythematosus |
| M32.19 | ICD10CM | Other organ or system involvement in systemic lupus erythematosus |
| M32.8 | ICD10CM | Other forms of systemic lupus erythematosus |
| M32.9 | ICD10CM | Systemic lupus erythematosus, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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