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Drug overview for SAPHNELO (anifrolumab-fnia):
Generic name: anifrolumab-fnia (AN-i-FROL-ue-mab)
Drug class: Immunosuppressive - Interferon Inhibitor, Monoclonal Ab
Therapeutic class: Immunosuppressive Agents
Anifrolumab-fnia, a type I interferon (IFN) receptor antagonist, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
Generic name: anifrolumab-fnia (AN-i-FROL-ue-mab)
Drug class: Immunosuppressive - Interferon Inhibitor, Monoclonal Ab
Therapeutic class: Immunosuppressive Agents
Anifrolumab-fnia, a type I interferon (IFN) receptor antagonist, is an immunosuppressive agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for SAPHNELO (anifrolumab-fnia) have been approved by the FDA:
Indications:
Systemic lupus erythematosus
Professional Synonyms:
Disseminated lupus erythematosus
Lupus erythematosus syndrome
Indications:
Systemic lupus erythematosus
Professional Synonyms:
Disseminated lupus erythematosus
Lupus erythematosus syndrome
The following dosing information is available for SAPHNELO (anifrolumab-fnia):
No enhanced Dosing information available for this drug.
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.
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 | DOSING INSTRUCTIONS |
|---|---|---|
| SAPHNELO 300 MG/2 ML VIAL | Maintenance | Adults infuse 300 mg over 30 minute(s) by intravenous route every 4 weeks |
No generic dosing information available.
The following drug interaction information is available for SAPHNELO (anifrolumab-fnia):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Vaccines; Live BCG/Selected Immunosuppressive Agents 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) 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) |
ACAM2000 (NATIONAL STOCKPILE), ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, BCG (TICE STRAIN), BCG VACCINE (TICE STRAIN), DENGVAXIA, ERVEBO (NATIONAL STOCKPILE), FLUMIST TRIVALENT 2024-2025, IXCHIQ, M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
ABECMA, ABRILADA(CF), ABRILADA(CF) PEN, ABRILADA(CF) PEN (2 PACK), ACTEMRA, ACTEMRA ACTPEN, ACTIMMUNE, ADALIMUMAB-AACF(CF), ADALIMUMAB-AACF(CF) (2 PK), ADALIMUMAB-AACF(CF) PEN (2 PK), ADALIMUMAB-AACF(CF) PEN CROHNS, ADALIMUMAB-AACF(CF) PEN PS-UV, ADALIMUMAB-AATY(CF) (2 PACK), ADALIMUMAB-AATY(CF) (2 PK), ADALIMUMAB-AATY(CF) AI CROHNS, ADALIMUMAB-AATY(CF) AUTOINJ(2), ADALIMUMAB-AATY(CF) AUTOINJECT, ADALIMUMAB-ADAZ(CF), ADALIMUMAB-ADAZ(CF) PEN, ADALIMUMAB-ADBM(CF), ADALIMUMAB-ADBM(CF) PEN, ADALIMUMAB-ADBM(CF) PEN CROHNS, ADALIMUMAB-ADBM(CF) PEN PS-UV, ADALIMUMAB-ADBM(CF)PEN, ADALIMUMAB-FKJP(CF), ADALIMUMAB-FKJP(CF) PEN, ADALIMUMAB-RYVK(CF), ADALIMUMAB-RYVK(CF) AUTOINJECT, ADCETRIS, ALFERON N, ALYMSYS, AMJEVITA(CF), AMJEVITA(CF) AUTOINJECTOR, AMTAGVI, ARCALYST, ARZERRA, AUCATZYL, AVASTIN, AVONEX, AVONEX (4 PACK), AVONEX PEN, AVONEX PEN (4 PACK), AVSOLA, BAVENCIO, BENLYSTA, BESPONSA, BETASERON, BIMZELX, BIMZELX AUTOINJECTOR, BIZENGRI, BLINCYTO, BREYANZI, BREYANZI CD4 COMPONENT, BREYANZI CD8 COMPONENT, BRIUMVI, CAMPATH, CARVYKTI, CIMZIA, CIMZIA (2 PACK), COLUMVI, COSENTYX, COSENTYX (2 SYRINGES), COSENTYX SENSOREADY (2 PENS), COSENTYX SENSOREADY PEN, COSENTYX SYRINGE, COSENTYX UNOREADY PEN, CYLTEZO(CF), CYLTEZO(CF) PEN, CYLTEZO(CF) PEN CROHN'S-UC-HS, CYLTEZO(CF) PEN PSORIASIS-UV, DANYELZA, DARZALEX, DARZALEX FASPRO, ELAHERE, ELREXFIO, ENBREL, ENBREL MINI, ENBREL SURECLICK, ENHERTU, ENSPRYNG, ENTYVIO, ENTYVIO PEN, EPKINLY, ERBITUX, GAMIFANT, GAZYVA, HADLIMA, HADLIMA PUSHTOUCH, HADLIMA(CF), HADLIMA(CF) PUSHTOUCH, HERCEPTIN, HERCEPTIN HYLECTA, HERCESSI, HERZUMA, HULIO(CF), HULIO(CF) PEN, HUMIRA, HUMIRA PEN, HUMIRA(CF), HUMIRA(CF) PEN, HUMIRA(CF) PEN CROHN'S-UC-HS, HUMIRA(CF) PEN PSOR-UV-ADOL HS, HYRIMOZ, HYRIMOZ PEN, HYRIMOZ(CF), HYRIMOZ(CF) PEDIATRIC CROHN'S, HYRIMOZ(CF) PEN, HYRIMOZ(CF) PEN CROHN-UC START, HYRIMOZ(CF) PEN PSORIASIS, ILARIS, IMDELLTRA, IMFINZI, INFLECTRA, INFLIXIMAB, JEMPERLI, KADCYLA, KANJINTI, KESIMPTA PEN, KEVZARA, KEYTRUDA, KINERET, KYMRIAH, LEMTRADA, LOQTORZI, LUNSUMIO, MONJUVI, MVASI, MYLOTARG, NULOJIX, OCREVUS, OCREVUS ZUNOVO, OGIVRI, ONTRUZANT, OPDIVO, OPDIVO QVANTIG, OPDUALAG, ORENCIA, ORENCIA CLICKJECT, OTULFI, PADCEV, PEGASYS, PERJETA, PHESGO, PLEGRIDY, PLEGRIDY PEN, POLIVY, POTELIGEO, PYZCHIVA, REBIF, REBIF REBIDOSE, REMICADE, RENFLEXIS, RIABNI, RITUXAN, RITUXAN HYCELA, RUXIENCE, SARCLISA, SELARSDI, SIMLANDI(CF), SIMLANDI(CF) AUTOINJECTOR, SIMPONI, SIMPONI ARIA, SIMULECT, STELARA, STEQEYMA, SYLVANT, TALTZ AUTOINJECTOR, TALTZ AUTOINJECTOR (2 PACK), TALTZ AUTOINJECTOR (3 PACK), TALTZ SYRINGE, TALVEY, TECARTUS, TECELRA, TECENTRIQ, TECENTRIQ HYBREZA, TECVAYLI, TEVIMBRA, TOFACITINIB CITRATE, TOFIDENCE, TRAZIMERA, TRODELVY, TRUXIMA, TYENNE, TYENNE AUTOINJECTOR, TZIELD, UNITUXIN, UPLIZNA, USTEKINUMAB, USTEKINUMAB-AEKN, USTEKINUMAB-TTWE, VECTIBIX, VEGZELMA, WEZLANA, XELJANZ, XELJANZ XR, YESCARTA, YESINTEK, YUFLYMA(CF) (2 PACK), YUFLYMA(CF) AI CROHN'S-UC-HS, YUFLYMA(CF) AUTOINJECT (2 PCK), YUFLYMA(CF) AUTOINJECTOR, YUSIMRY(CF) PEN, ZEVALIN, ZIRABEV, ZYMFENTRA, ZYMFENTRA (2 PACK), ZYMFENTRA PEN (2 PACK), ZYNLONTA, ZYNYZ |
There are 0 moderate interactions.
The following contraindication information is available for SAPHNELO (anifrolumab-fnia):
Drug contraindication overview.
History of anaphylactic reaction to anifrolumab.
History of anaphylactic reaction to anifrolumab.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Severe infection |
There are 0 moderate contraindications.
The following adverse reaction information is available for SAPHNELO (anifrolumab-fnia):
Adverse reaction overview.
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.
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.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Herpes zoster |
Hypersensitivity drug reaction Infection |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Malignancy |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchitis Cough Pharyngitis Upper respiratory infection |
Arthralgia Back pain Chest pain Dizziness Fatigue Headache disorder Nausea Pain in extremities Peripheral edema Sinusitis Urinary tract infection Vomiting |
| Rare/Very Rare |
|---|
|
Blurred vision Depression Diabetes mellitus General weakness Hemorrhoids Hyperglycemia Hypertension |
The following precautions are available for SAPHNELO (anifrolumab-fnia):
Safety and efficacy of anifrolumab in pediatric patients less than 18 years of age are not established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for SAPHNELO (anifrolumab-fnia):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SAPHNELO (anifrolumab-fnia)'s list of indications:
| Systemic lupus erythematosus | |
| M32 | Systemic lupus erythematosus (SLe) |
| M32.0 | Drug-induced systemic lupus erythematosus |
| M32.1 | Systemic lupus erythematosus with organ or system involvement |
| M32.10 | Systemic lupus erythematosus, organ or system involvement unspecified |
| M32.11 | Endocarditis in systemic lupus erythematosus |
| M32.12 | Pericarditis in systemic lupus erythematosus |
| M32.13 | Lung involvement in systemic lupus erythematosus |
| M32.14 | Glomerular disease in systemic lupus erythematosus |
| M32.15 | Tubulo-interstitial nephropathy in systemic lupus erythematosus |
| M32.19 | Other organ or system involvement in systemic lupus erythematosus |
| M32.8 | Other forms of systemic lupus erythematosus |
| M32.9 | Systemic lupus erythematosus, unspecified |
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