Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions reported were cough (50%) and vomiting (33%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc.
at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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.
REVCOVI was administered intramuscularly in two prospective, open-label, single-arm, multi‑center studies to evaluate efficacy, safety, tolerability, and pharmacokinetics in patients with ADA-SCID: Study 1 was performed in the US and Study 2 was performed in Japan [see Clinical Studies ( 14 )] .
Overall, 10 patients were treated and adverse reactions reported are summarized below.
Study 1 Study 1 is a one-way crossover study, conducted in the US, to evaluate the safety, efficacy, and pharmacokinetics of REVCOVI in patients with ADA‑SCID who were receiving therapy with Adagen.
Six patients, 8 to 37 years of age enrolled in the study.
Patients' exposure to REVCOVI ranged from 2 weeks to 146 weeks.
No deaths were reported and one patient discontinued treatment due to injection site pain associated with an earlier drug product formulation that was consequently modified.
5 WARNINGS AND PRECAUTIONS Injection Site Bleeding in Patients with Thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia;
should not be used if thrombocytopenia is severe.
( 5.1 ) Delay in Improvement of Immune Function: Protect immune deficient patients from infections until improvement in immune function.
( 5.2 ) 5.1 Injection Site Bleeding in Patients with Thrombocytopenia Since REVCOVI is administered by IM injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.
5.2 Delay in Improvement of Immune Function Maintain precautions to protect immune deficient patients from infections until improvement in immune function has been achieved.
Like all medications, Revcovi can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: