INDICATION
PYQUVI™ is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
IMPORTANT SAFETY INFORMATION
PYQUVI is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients.
WARNINGS AND PRECAUTIONS
- Alterations in Endocrine Function: Corticosteroids can cause serious and life-threatening endocrine alterations, especially with chronic use. Monitor for Cushing's syndrome, hyperglycemia, and adrenal insufficiency after withdrawal. Risk is higher in patients with hypopituitarism, primary adrenal insufficiency, congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma. Acute adrenal insufficiency or "withdrawal syndrome" may occur if discontinued abruptly and can be fatal; taper gradually. Dose may need to be increased during times of medical stress.
- Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe or fatal. Signs of infection may be masked. Advise patients/caregivers to report recent infections or vaccinations. Patients without prior chickenpox or measles should avoid exposure and contact their healthcare provider immediately if exposed.
- Alterations in Cardiovascular/Renal Function: Monitor blood pressure; dietary salt restriction and potassium supplementation may be needed.
- Gastrointestinal (GI) Perforation: Risk is increased in patients with certain GI disorders (eg, active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, inflammatory bowel disease). Signs may be masked.
- Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, depression, and psychosis. Advise patients to seek medical attention if symptoms develop or worsen.
- Effects on Bones: Prolonged use increases risk of osteoporosis, and vertebral and long bone fractures. Monitor bone density with chronic use.
- Ophthalmic Effects: May cause cataracts, ocular infections, or glaucoma. If corticosteroids are used for >6 weeks, monitor intraocular pressure.
- Vaccination: Do not administer live or live-attenuated vaccines during immunosuppressive corticosteroid therapy. Administer such vaccines at least 4 to 6 weeks before starting PYQUVI.
- Serious Skin Rashes: Toxic epidermal necrolysis has been reported. Discontinue at the first sign of rash, unless the rash is clearly not drug related.
- Effects on Growth and Development: Long-term use of corticosteroids may slow growth and development in children.
- Thromboembolic Events: Observational studies have shown an increased risk. Use with caution in at-risk patients.
ADVERSE REACTIONS
The most common adverse reactions (≥10% and greater than placebo) are Cushingoid appearance, weight gain, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis.
DRUG INTERACTIONS
Moderate or strong CYP3A4 inhibitors: Use one third of the recommended PYQUVI dose.
Moderate or strong CYP3A4 inducers: Avoid concomitant use as efficacy may be reduced.
To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
