Emrosi

(Minocycline Hydrochloride Extended-Release)

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Emrosi Prescribing Information

The recommended dosage of EMROSI is one capsule taken orally, once daily. Higher doses have not shown to be of additional benefit in the treatment of rosacea.

EMROSI may be taken with or without food

[see

12.3 Pharmacokinetics

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 1: Plasma Pharmacokinetic Parameters [Mean (%CV)] for EMROSI (40 mg)

C_max

(ng/mL)

T_max*

(hr)

AUC_inf

(ng.hr/mL)

t_1/2

(hr)

EMROSI (Fasting)

243.9

(37.3)

1.50

(1.00 – 4.17)

3933.6

(31.2)

14.67

(26.7)

EMROSI (Fed)

225.0

(16.7)

4.50

(3.00 – 8.00)

4404.1

(21.0)

14.93

(21.5)

Note: * Median (Range)

In Study 2, minocycline plasma PK following EMROSI single (Day 1) and after repeated (Day 21) once daily administrations in eight (8) subjects were found to be similar with overlapping ranges. The mean C_maxwas 382.83 ng/mL versus 337.74 ng/mL and AUC_0-24was 3549.64 ng*hr/mL versus 3957.62 ng*hr/mL, respectively on Day 1 versus Day 21.

Absorption:

In Study 1, the median plasma T_maxof minocycline from EMROSI was 1.50 hours (1.00 - 4.17). In Study 2, the median plasma T_maxvalues of minocycline from EMROSI on Day 1 and Day 21 were 1.75 and 1.5 hours, respectively.

Effect of Food:

Following administration of EMROSI with a high-fat meal (1011 Kcal, 53% fat), T_maxwas delayed by approximately 3 hours. The high fat meal did not impact the C_maxhowever, the AUC_infwas increased by 15.26%

[see Dosage and Administration (2)].

Distribution:

Minocycline is lipid soluble and distributes into the skin and sebum. In Study 1, the mean apparent volume of distribution (Vz/F) values of minocycline following oral administration of EMROSI at fasting and fed condition were 229.61 (±67.83) L and 199.83 (±43.71) L, respectively.

Elimination:

The mean apparent elimination half-life (t_½) of minocycline from EMROSI was approximately 15 hours independent of fasting and fed dosing condition.

]

. Ingestion of food along with EMROSI may help to reduce the risk of esophageal irritation and ulceration.

Swallow the capsule whole. Do not crush or chew the extended-release capsule.

EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines

[see

5.1 Hypersensitivity Reaction and Serious Skin Reactions

Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue EMROSI immediately.

The following clinically significant adverse reactions are described elsewhere in the labeling:

Serious Skin/Hypersensitivity Reactions

[see

5.1 Hypersensitivity Reaction and Serious Skin Reactions
Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue EMROSI immediately.
]
Clostridioides difficile
-Associated Diarrhea (Antibiotic-Associated Colitis)

[see

Warnings and Precautions (5.4)]
Hepatotoxicity

[see

5.5 Hepatotoxicity
Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne. Discontinue EMROSI if liver injury is suspected.
]
Central Nervous System Effects

[see

5.6 Central Nervous System Effects
Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on EMROSI. These symptoms may disappear during therapy and usually rapidly disappear when the drug is discontinued.
]
Idiopathic Intracranial Hypertension

[see

5.7 Idiopathic Intracranial Hypertension
Idiopathic Intracranial hypertension has been associated with the use of tetracyclines. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and EMROSI because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension.
Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize.
]

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a- tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. Its molecular formula is C
₂₃H
₂₇N
₃O
₇•HCl with a molecular weight of 493.95. Minocycline hydrochloride has the following structure:

Referenced Image

Minocycline hydrochloride is a yellow, hygroscopic, crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol (96%). A 1% w/v solution in water has pH between 3.5 and 4.5.

Each EMROSI extended-release capsule contains 40 mg of minocycline (equivalent to 43.19 mg of minocycline hydrochloride) as 10 mg immediate-release and 30 mg extended-release beads and the following inactive ingredients: ethyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, Opadry
^®clear, polyethylene glycol 400, triethyl citrate and talc. Opadry
^®clear contains: hydroxypropyl cellulose and hypromellose. Capsule shell contains gelatin, iron oxide red and titanium dioxide. White ink contains ammonia, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, titanium dioxide and shellac.

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