Brand Name
Panretin
Generic Name
Alitretinoin
View Brand Information FDA approval date: September 10, 2019
Classification: Retinoid
Form: Gel
What is Panretin (Alitretinoin)?
Panretin ® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma. Panretin ® gel is not indicated when systemic anti-KS therapy is required . There is no experience to date using Panretin ® gel with systemic anti-KS treatment.
Approved To Treat
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Brand Information
PANRETIN (alitretinoin)
1DESCRIPTION
Panretin
Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C
2INDICATIONS & USAGE
Panretin
3CONTRAINDICATIONS
Panretin
4WARNINGS
Pregnancy: Panretin® gel could cause fetal harm if significant absorption were to occur in a pregnant woman. 9-cis-Retinoic acid has been shown to be teratogenic in rabbits and mice. An increased incidence of fused sternebrae and limb and craniofacial defects occurred in rabbits given oral doses of 0.5 mg/kg/day (about five times the estimated daily human topical dose on a mg/m2 basis, assuming complete systemic absorption of 9-cis-retinoic acid, when Panretin® gel is administered as a 60 g tube over 1 month in a 60 kg human) during the period of organogenesis. Limb and craniofacial defects also occurred in mice given a single oral dose of 50 mg/kg on day eleven of gestation (about 127 times the estimated daily human topical dose on a mg/m2 basis). Oral 9-cis-retinoic acid was also embryocidal, as indicated by early resorptions and post-implantation loss when it was given during the period of organogenesis to rabbits at doses of 1.5 mg/kg/day (about 15 times the estimated daily human topical dose on a mg/m2 basis) and to rats at doses of 5 mg/kg/day (about 25 times the estimated daily human topical dose on a mg/m2 basis). Animal reproduction studies with topical 9-cis-retinoic acid have not been conducted. It is not known whether topical Panretin® gel can modulate endogenous 9-cis-retinoic acid levels in a pregnant woman nor whether systemic exposure is increased by application to ulcerated lesions or by duration of treatment. There are no adequate and well-controlled studies in pregnant women. If Panretin® gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant.
5ADVERSE REACTIONS
The safety of Panretin
TABLE 2: Adverse Events with an Incidence of at Least 5% at the Application Site in Either Controlled Study in Patients Receiving Panretin
To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 or FDA at 1-800-FDA-1800 or www.fda.gov/medwatch
6OVERDOSAGE
There has been no experience with acute overdose of Panretin
7DOSAGE & ADMINISTRATION
Panretin
8HOW SUPPLIED
Panretin
(Rev. 11/2024)
9SPL PATIENT PACKAGE INSERT SECTION
PanretinPatient’s Instructions for Use
(For topical use only)
(For topical use only)
Your health care provider has prescribed Panretin
9.1WARNINGS
DO NOT apply gel on or near mucosal surfaces of the body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum or anus.
9.2HOW TO APPLY
Apply Panretin
9.3WHEN TO APPLY
Panretin
9.4YOU SHOULD AVOID…
You should avoid applying the gel to areas of healthy skin around a KS lesion. Exposure of healthy skin to Panretin® gel may cause unnecessary irritation or redness.
You should avoid showering, bathing, or swimming until at least three (3) hours after any application, if possible.
You should avoid covering the KS lesions treated with gel with any bandage or material other than loose clothing.
You should avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
You should avoid the use of other topical products on your treated KS lesions. Mineral oil may be used between Panretin® gel applications in order to help prevent excessive dryness or itching. However, mineral oil should not be applied for at least two (2) hours before or after the application of Panretin® gel.
You should avoid scratching the treated areas.
You should avoid showering, bathing, or swimming until at least three (3) hours after any application, if possible.
You should avoid covering the KS lesions treated with gel with any bandage or material other than loose clothing.
You should avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
You should avoid the use of other topical products on your treated KS lesions. Mineral oil may be used between Panretin® gel applications in order to help prevent excessive dryness or itching. However, mineral oil should not be applied for at least two (2) hours before or after the application of Panretin® gel.
You should avoid scratching the treated areas.
9.5WHAT TO EXPECT
Do not be discouraged if you do not see immediate improvement.
9.6HOW QUICKLY CAN I EXPECT PANRETIN® GEL TO WORK?
Be patient. Panretin
9.7OTHER INFORMATION
The opening of the Panretin
To open, use the pointed portion of the cap to puncture the metal safety seal.
Always use the cap to close the tube tightly after each use.
Store at room temperature. Keep away from heat.
9.8IF YOU HAVE QUESTIONS…
If you have any questions about your treatment, talk with your health care provider.
(Rev. 11/2024)
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 59212-601-22
Panretin
(alitretinoin) 0.1%
Panretin
(alitretinoin) 0.1%