sohonos

Obtain a negative pregnancy test in females of reproductive potential before initiation of SOHONOS ( 2.1 ) Recommended dosage includes a chronic daily dose, which can be increased for flare-up symptoms ( 2.2 ) For adults and pediatric patients 14 years and older: Recommended dosage is 5 mg once daily, with an increase in dose at the time of a flare-up to 20 mg once daily for 4 weeks, followed by 10 mg once daily for 8 weeks for a total of 12 weeks (20/10 mg flare-up treatment) ( 2.2 ) For pediatric patients under 14 years: Weight-adjusted for daily and flare-up dosing. Recommended daily dosage range from 2.5 to 5 mg. Refer to Table 1 in Full Prescribing Information for complete pediatric dosing ( 2.2 ) Take SOHONOS with food preferably at same time each day ( 2.3 ). Reduce the dose in the event of adverse reactions as appropriate ( 2.4 ) See Full Prescribing Information for complete dosing instructions ( 2 ) 2.1 Pregnancy Testing Prior to Treatment with SOHONOS For females of reproductive potential, obtain a negative pregnancy test within one week prior to initiating and periodically during SOHONOS therapy . If pregnancy occurs, stop SOHONOS treatment immediately and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity. [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. 2.2 Recommended Dosage and Duration Dosage…

The following clinically significant adverse reactions are described elsewhere in the labeling: Premature Epiphyseal Closure in Growing Pediatric Patients [see Warnings and Precautions (5.2) ] Mucocutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Metabolic Bone Disorders [see Warnings and Precautions (5.4) ] Psychiatric Disorders [see Warnings and Precautions (5.5) ] Night Blindness [see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence ≥10%) are dry skin, lip dry, arthralgia, pruritus, pain in extremity, rash, alopecia, erythema, headache, back pain, skin exfoliation, nausea, musculoskeletal pain, myalgia, dry eye, hypersensitivity, peripheral edema, and fatigue ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IPSEN Biopharmaceuticals, Inc at 1-855-463-5127 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. The safety of SOHONOS was evaluated in clinical studies that enrolled a total of 164 subjects with FOP, including 139 subjects in the indicated population of ages 8 years and above for females and 10 years and above for males (8/10 years…

SOHONOS is contraindicated in the following patients: During Pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . A history of allergy or hypersensitivity to retinoids, or to any component of SOHONOS. Anaphylaxis and other allergic reactions have occurred with other retinoids. [see Description (11) ]. Pregnancy ( 4 , 5.1 , 8.1 ) Hypersensitivity to retinoids or any component of SOHONOS ( 4 , 11 )

No clinical experience with an overdose of SOHONOS has been reported. SOHONOS is a derivative of vitamin A. In case of accidental overdose, signs of hypervitaminosis A could appear, including severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Any overdose should be treated with supportive care according to the signs and symptoms exhibited by the patient.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

CYP3A4 Inhibitors: May increase SOHONOS exposure. Avoid concomitant use of strong/moderate CYP3A4 inhibitors. If concomitant use of moderate CYP3A4 inhibitors is unavoidable, reduce the dose of SOHONOS by half ( 2.5 , 7.1 ) CYP3A4 Inducers: May decrease SOHONOS exposure. Avoid concomitant use of strong/moderate CYP3A4 inducers ( 7.1 ) Vitamin A: May cause additive effects ( 7.2 ) Tetracyclines: Avoid concomitant use with SOHONOS ( 7.3 ) Systemic Corticosteroids: No clinically significant drug interaction is expected with concomitant use of SOHONOS ( 7.4 ) 7.1 Effect of Other Drugs on SOHONOS Clinically significant drug interactions affecting the exposure of SOHONOS are listed in Table 6. Table 6. Drugs that affect exposure of SOHONOS. Strong CYP3A Inhibitors Clinical Impact Co-administration of SOHONOS with strong CYP3A4 inhibitors increased the exposures of palovarotene [see Clinical Pharmacology (12.3) ] , which may increase the risk of SOHONOS adverse reactions. Prevention or Management Avoid concomitant use of a strong CYP3A4 inhibitor during SOHONOS treatment [see Dosage and Administration (2.5) ] . Moderate CYP3A Inhibitors Clinical Impact Co-administration of SOHONOS with moderate CYP3A4 inhibitors may increase the exposure of palovarotene [see Clinical Pharmacology (12.3) ] , which may increase the risk of SOHONOS adverse reactions. Prevention or Management Avoid concomitant use of a moderate CYP3A4 inhibitor with SOHONOS, if possible. If co-administration will occur, reduce the SOHONOS dose by half when co-administered with moderate CYP3A inhibitors [see Dosage and Administration (2.5) ] . Strong CYP3A Inducers Clinical Impact Co-administration of SOHONOS with strong CYP3A4 inducers decreased the exposure of palovarotene [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of SOHONOS. Prevention or Management Avoid concomitant use of strong CYP3A4 inducers with SOHONOS. [see Dosage and Administration (2.5) ] . Moderate CYP3A Inducers Clinical Impact Co-administration of moderate CYP3A4 inducers with palovarotene may decrease palovarotene exposure [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of SOHONOS. Prevention or Management Avoid concomitant use of moderate CYP3A4 inducers with SOHONOS. 7.2 Vitamin A Palovarotene belongs to the same pharmacological class as vitamin A. Therefore, the use of both vitamin A and SOHONOS at the same time may lead to additive effects. Concomitant administration of vitamin A in doses higher than the recommended daily allowance (RDA) and/or other oral retinoids with SOHONOS must be avoided because of the risk of hypervitaminosis A. 7.3 Tetracyclines Systemic retinoid use has been associated with cases of benign intracranial hypertension (also called pseudotumor cerebri), some of which involved the concomitant use of tetracyclines. Avoid coadministration of SOHONOS with tetracycline derivatives [see Adverse Reactions (6.1) ] . 7.4 Systemic Corticosteroids No clinically significant drug-drug interaction is expected when SOHONOS is co-administered with prednisone [see Clinical Pharmacology (12.3) ] .