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Saphnelo

  • Generic Name: anifrolumab-fnia injection
  • Brand Name: Saphnelo

Saphnelo (Anifrolumab-fnia Injection) side effects drug center

 

PROFESSIONAL

SIDE EFFECTS

Saphnelo Side Effects Center

What Is Saphnelo?

Saphnelo (anifrolumab-fnia) is a type I interferon (IFN) receptor antagonist used to treat adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.

What Are Side Effects of Saphnelo?

Side effects of Saphnelo include:

 

Dosage for Saphnelo

The recommended dosage of Saphnelo is 300 mg as an intravenous infusion over 30-minute period every 4 weeks. 


Saphnelo In Children

The safety and efficacy of Saphnelo in pediatric patients less than 18 years of age have not been established. 

 

What Drugs, Substances, or Supplements Interact with Saphnelo?
Saphnelo may interact with other medicines.

Tell your doctor all medications and supplements you use.


Saphnelo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Saphnelo; it is unknown how it would affect a fetus. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to Saphnelo during pregnancy. It is unknown if Saphnelo passes into breast milk or if it would affect a nursing infant. Consult your doctor before breastfeeding. 

Additional Information

Our Saphnelo (anifrolumab-fnia) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 

 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Saphnelo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are also discussed elsewhere in the labeling:

  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions Including Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Malignancy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SAPHNELO was assessed through 52 weeks in patients with moderate to severe SLE who received anifrolumab-fnia 300 mg by intravenous infusion every 4 weeks (N=459), compared to placebo (N=466) in controlled clinical trials (Trials 1, 2 and 3) [see Clinical Studies]. The population studied had a mean age of 41 years (range: 18 to 69), of which 93% were female, 60% White, 13% Black/African American, and 10% Asian.

In the controlled-clinical trials, adverse reactions, irrespective of causality, were reported in 87% of patients receiving SAPHNELO and 79% of patients receiving placebo.

Adverse reactions that occurred at greater than or equal to 2% incidence are shown in Table 1.

Table 1 Adverse Reactions Occurring in ≥2% of Patients on SAPHNELO 300 mg (Trials 1, 2 and 3) at 52 weeks

Adverse Reaction SAPHNELO
(N=459)
%		 Placebo
(N=466)
%
Upper respiratory tract infection* 34 23
Bronchitis† 11 5.2
Infusion-related reactions 9.4 7.1
Herpes Zoster 6.1 1.3
Respiratory tract infection‡ 3.3 1.5
Hypersensitivity 2.8 0.6
All patients received standard therapy
* Upper respiratory tract infections (including Upper respiratory tract infections, Nasopharyngitis, Pharyngitis)
† Bronchitis (including Bronchitis, Bronchitis viral, Tracheobronchitis)
‡ Respiratory tract infection (including Respiratory tract infection, Respiratory tract infection viral, Respiratory tract infection bacterial)

Specific Adverse Reactions

Infections

In the controlled-clinical trials, infections were reported in a greater proportion of patients while on treatment with SAPHNELO compared to placebo (69.7% [320/459] versus 55.4% [258/466]), corresponding to exposure-adjusted incidence rates (EAIR) of 141.8 and 99.9 per 100 patient years (PY), respectively.

Serious Infections

In the controlled-clinical trials, the incidence of serious infections while on treatment was 4.8% (22/459) in patients treated with SAPHNELO compared with 5.6% (26/466) in patients receiving placebo, corresponding to EAIR of 5.4 and 6.6 per 100 PY, respectively. The most frequent serious infection was pneumonia.

In the controlled-clinical trials, fatal infections occurred in 0.4% of patients receiving SAPHNELO and 0.2% of the patients receiving placebo.
Herpes Zoster

In the controlled-clinical trials, the incidence of herpes zoster in patients while on treatment with SAPHNELO was 6.1% (28/459) and 1.3% (6/466) in patients on placebo, corresponding to EAIRs of 6.9 and 1.5 per 100 PY, respectively. Cases with multidermatomal involvement and disseminated presentation have been reported. Of the 28 SAPHNELO-treated patients with herpes zoster, 2 experienced disseminated disease requiring hospitalization compared to none among patients who received placebo.

Hypersensitivity Reactions Including Anaphylaxis

During the drug development program, there was one report of an anaphylactic reaction in a patient who received 150 mg anifrolumab-fnia, and 2 reports of angioedema after 300 mg. In general, the hypersensitivity reactions were predominantly mild or moderate in intensity and did not lead to discontinuation of SAPHNELO.

In the controlled-clinical trials, hypersensitivity reactions occurred in 2.8% (13/459) of patients while on treatment with SAPHNELO and 0.6% (3/466) of patients on placebo, corresponding to EAIR of 3.2 and 0.7 per 100 PY, respectively. Serious hypersensitivity reactions were reported for 0.6% (3/459) of patients receiving SAPHNELO, including angioedema (n=2).

Infusion-related Reactions

Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness.

In the controlled-clinical trials, the incidence of infusion-related reactions while on treatment was 9.4% (43/459) in patients while on treatment with SAPHNELO and 7.1% (33/466) in patients on placebo, corresponding to EAIRs of 11.1 and 8.7 per 100 PY, respectively.

Malignancies

In controlled-clinical trials, malignancies (excluding non-melanoma skin cancers) were observed in 0.7% (3/459) and 0.6% (3/466) of patients receiving SAPHNELO and placebo, corresponding to EAIR of 0.7 and 0.7 per 100 PY, respectively. Malignant neoplasm (including non-melanoma skin cancers) was reported for 1.3% (6/459) patients receiving SAPHNELO, compared to 0.6% (3/466) patients receiving placebo (EAIR: 1.3 and 0.7 per 100 PY, respectively). The malignancies that were reported in more than one patient treated with SAPHNELO included breast cancer and squamous cell carcinoma.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to anifrolumab-fnia in the trials described below with the incidence of antibodies in other trials or to other products may be misleading.

In Trials 2 and 3, anti-anifrolumab-fnia antibodies were detected in 6 of 352 (1.7%) patients who received SAPHNELO at the recommended dosing regimen during the 60-week study period. The clinical relevance of the presence of antianifrolumab-fnia antibodies is not known.

DRUG INTERACTIONS

No formal drug interaction studies have been conducted.

Read the entire FDA prescribing information for Saphnelo (Anifrolumab-fnia Injection)

&Copy; Saphnelo Patient Information is supplied by Cerner Multum, Inc. and Saphnelo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.