Panretin (alitretinoin): FDA label

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Indications

1.1Kaposi’s Sarcoma

PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS).

Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

Warnings and precautions

Embryo-Fetal Toxicity : Can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception. ( 5.1 . 8.1 , 8.3 )
Photosensitivity : Minimize exposure to sunlight and sunlamps. ( 5.2 )
DEET toxicity : Do not use DEET-containing products ( 5.3 )

5.1Embryo-Fetal Toxicity Based

on data from animal studies and its mechanism of action, PANRETIN GEL can cause fetal harm when administered to a pregnant woman. Oral administration of alitretinoin to pregnant animals during the period of organogenesis was teratogenic and embryo-lethal at exposures 5 times the estimated daily human topical dose. Advise women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during treatment with PANRETIN GEL and for 1 week after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

Adverse reactions

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

Photosensitivity [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (> 5%) at the application site are rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 PANRETIN GEL was assessed in two multicenter, prospective, randomized, double-blind, vehicle-controlled trials (Trial 1 and Trial 2) in patients with cutaneous lesions of AIDS-related KS [see Clinical Studies ( 14.1 )] .

In a pooled analysis of both trials, the most common adverse reactions in ≥ 5% of patients were rash, pain, paresthesia, pruritis, exfoliative dermatitis, edema, and skin disorder. In Trial 1, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 10% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control). Adverse reactions led to withdrawal from the study in 7% of patients.

In Trial 2, severe local skin adverse reactions (erythema and edema with or without vesiculation) occurred in 6% of patients during the first 12 weeks of treatment (versus 0% in the vehicle control) and 1 patient withdrew due to severe skin irritation. Table 1 lists the most common application site adverse reactions that occurred in a least 5% of patients during the double-blind phase who received PANRETIN GEL in either of the two controlled studies.

TABLE 1: Adverse Reactions at Application Site in Trial 1 and 2 in ≥ 5% of Patients Treated with PANRETIN GEL A dverse Event Term Trial 1 Trial 2 PANRETIN GEL N=134 % Vehicle Gel N=134 % PANRETIN GEL N=36 % Vehicle Gel N=46 % Rash 1 77 11 25 4 Pain 2 34 7 0 4 Pruritus 3 11 4 8 4 Exfoliative dermatitis 4 9 2 3 0 Skin disorder 5 8 1 0 0 Edema 6 8 3 3 0 Parethesia 7 3 0 22 7 Includes Investigator terms: 1 Erythema, scaling, irritation, redness, rash, dermatitis 2 Burning, pain 3 Itching, pruritus 4 Flaking, peeling, desquamation, exfoliation 5 Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6 Edema, swelling, inflammation 7 Stinging, tingling

Panretin

Indications

1.1Kaposi’s Sarcoma

Contraindications

Warnings and precautions

5.1Embryo-Fetal Toxicity Based

Two medicines in one question?

5.3Toxicity with DEET-Containing Products

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information

At a glance

Guidelines