EMROSI (minocycline hydrochloride)

EMROSI is not bioequivalent to any other minocycline products. The pharmacokinetics of minocycline following administration of EMROSI was investigated in two studies that enrolled 32 healthy, adult subjects. In Study 1, the plasma pharmacokinetic parameters for EMROSI following single dose administration under fasting and fed states are presented in Table 1 .

Table 1Plasma Pharmacokinetic Parameters [Mean (%CV)] for EMROSI (40 mg) N C max (ng/mL) T max * (hr) AUC inf (ng.hr/mL) t 1/2 (hr) EMRO...

The safety and efficacy of EMROSI in the treatment of inflammatory lesions and erythema of rosacea was assessed in two 16-week, multi-center, randomized, double-blind, active- and placebo-controlled trials (MVOR-1 [NCT05296629] and MVOR-2 [NCT05343455]) in adults. In the two trials, a total of 653 subjects with papulopustular rosacea received EMROSI or doxycycline capsules 40 mg or placebo for up to 16 weeks. Subjects were required to have an inflammatory lesion count (papules and pustules) in the range 15-60 lesions and an Investigator’s Global Assessment (IGA) score of 3 (“moderate”) or 4 (“...

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Central Nervous System Effects [see Warnings and Precautions (5.6) ] Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7) ] The most comm...

EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines [see Warnings and Precautions (5.1) ]. Known hypersensitivity to any of the tetracyclines. ( 4 )

Serious Skin/Hypersensitivity Reactions: Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue EMROSI immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: The use of EMROSI during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-g...

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) 7.1 Anticoagulants Because tetracyclines have been shown to decrease plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Because bacteriostatic drugs may interfere with t...