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CHOOSE SAPHNELO TODAY FOR YOUR APPROPRIATE PATIENTS WITH SLE

 

 

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IMPORTANT SAFETY INFORMATION

 

 

CONTRAINDICATION
Hypersensitivity to the active substance or to any of the excipients listed.

 

WARNINGS AND PRECAUTIONS

  • Serious Infections: Anifrolumab increases the risk of respiratory infections and herpes zoster (disseminated herpes zoster events have been observed). SLE patients also taking immunosuppressants may be at higher risk of herpes zoster infections.
    Anifrolumab should be used with caution in patients with a chronic infection, a history of recurrent infections, or known risk factors for infection. Treatment with anifrolumab should not be initiated in patients with any clinically significant active infection until the infection resolves or is adequately treated. Patients should be instructed to seek medical advice if signs or symptoms of clinically significant infection occur. If a patient develops an infection, or is not responding to standard therapy, they should be closely monitored and careful consideration given to interrupting anifrolumab therapy until the infection resolves.
  • Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions including anaphylaxis have been reported following administration of anifrolumab .  In the placebo-controlled clinical trials, serious hypersensitivity reactions (including angioedema) were reported for 0.6% of patients receiving anifrolumab. In patients with a history of infusion-related reactions and/or hypersensitivity, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab. If a serious infusion-related or hypersensitivity reaction (e.g., anaphylaxis) occurs, administration of anifrolumab should be interrupted immediately, and appropriate therapy initiated.
  • Malignancy: The impact of Saphenlo on potential development of malignancies is not known.
  • Immunisation: No data are available on the immune response to vaccines. Prior to initiating therapy, completion of all appropriate immunisations should be considered according to current immunisation guidelines. Concurrent use of live or attenuated vaccines should be avoided in patients treated with anifrolumab.
  • Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies

INDICATION
Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

 

Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.

 

USE IN SPECIFIC POPULATIONS

Pregnancy: There are limited data (less than 300 pregnancy outcomes) from the use of Saphnelo in pregnant women. Animal studies are inconclusive with respect to reproductive toxicity. Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk.

Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established.

 

 

ADVERSE REACTIONS
The most commonly reported adverse reactions during anifrolumab treatment were upper respiratory tract infection (34%), bronchitis (11%), infusion-related reaction (9.4%) and herpes zoster (6.1%). The most common serious adverse reaction was herpes zoster (0.4%).

 

 

REPORTING
Gulf

AstraZeneca Office Address
Science Park Towers, South Tower, 7th Floor, Dubai.
Tel: 055 101 3321

*No testing required for anti-dsDNA or complement level. Patients with severe active lupus nephritis or severe active central nervous system lupus were excluded.1,6
†Disease control was defined as a response at week 52 with the use of BICLA, which measures SLE disease activity and requires at least one level of improvement in all moderately or severely affected organ systems, no new organ involvement, no worsening of disease activity, no discontinuation of treatment, and no use of restricted medication.2,7
BICLA, British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment; dsDNA, double-stranded DNA; SLE, systemic lupus erythematosus; ST, standard therapy.

 

 

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REFERENCES   SMPC

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