Absorica

INDICATIONS

Absorica™ is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, means “many” as opposed to “few or several” nodules. Because of significant adverse reactions associated with its use, Absorica™ should be reserved for patients with multiple severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Absorica™ is indicated only for those female patients who are not pregnant, because Absorica™ can cause severe birth defects [see CONTRAINDICATIONS].

Limitations of Use

A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience with isotretinoin has shown that patients may continue to improve following treatment with isotretinoin. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth [see WARNINGS AND PRECAUTIONS].

As a part of the iPLEDGE program, Absorica™ may only be administered to patients enrolled in the program [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Healthcare professionals who prescribe Absorica™ must be certified in the iPLEDGE program and must comply with the required monitoring to ensure safe use of Absorica™ [see WARNINGS AND PRECAUTIONS].

The required laboratory testing must be completed prior to dosing Absorica™.

Pregnancy Testing, and Contraceptive measures must be followed prior to dosing Absorica™ [see Use In Specific Populations].

Recommended Dosage

The recommended dosage range for Absorica™ is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid [see PATIENT INFORMATION].

The safety of once daily dosing with Absorica™ has not been established. Once daily dosing is not recommended.

Table 1: Absorica™ Dosing by Body Weight (Based on Administration With or Without Food)

Body Weight Total Daily (mg)
Kilograms Pounds 0.5 mg/kg 1 mg/kg 2 mg/kg
40 88 20 40 80
50 110 25 50 100
60 132 30 60 120
70 154 35 70 140
80 176 40 80 160
90 198 45 90 180
100 220 50 100 200

Dosage Range

In trials comparing 0.1, 0.5, and 1 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects, some of which may be dose-related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated.

Duration of Use

A normal course of treatment is 15 – 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Absorica™, even in low doses, has not been studied, and is not recommended. It is important that Absorica™ be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Absorica™ on bone loss is unknown [see WARNINGS AND PRECAUTIONS].

Laboratory Testing

Pregnancy Testing

[see Use in Specific Populations]

Lipid Profile

Perform a fasting lipid profile including triglycerides prior to use of Absorica™ [see WARNINGS AND PRECAUTIONS].

Liver Function Test

Perform liver function tests prior to use of Absorica™ [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Absorica™ is available in 10 mg, 20 mg, 30 mg and 40 mg capsules.

  • 10 mg capsules: Dark yellow capsule imprinted with black ink “G 240” on cap and “10” on the body
  • 20 mg capsules: Red opaque capsule imprinted with black ink “G 241” on cap and “20” on the body
  • 30 mg capsules: Brown opaque capsule imprinted with white ink “G 242” on cap and “30” on the body
  • 40 mg capsules: Brown and red capsule imprinted with white ink “G 325” on cap and “40” on the body

Storage And Handling

Absorica™ capsules (isotretinoin) are supplied as opaque hard gelatin capsules, imprinted as follows:

  • 10 mg capsules; Dark yellow capsule imprinted with black ink “G 240” on cap and “10” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-115-69
  • 20 mg capsules; Red opaque capsule imprinted with black ink “G 241” on cap and “20” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-116-69
  • 30 mg capsules; Brown opaque capsule imprinted with white ink “G 242” on cap and “30” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-117-69
  • 40 mg capsules; Brown and red capsule imprinted with white ink “G 325” on cap and “40” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-118-69
Storage and Handling

Store at 20° C - 25° C (68° F - 77° F), excursion permitted between 15° C - 30° C (59° F - 86° F) [see USP controlled room temperature]. Protect from light.

Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA. By: Galephar P R, Inc. Juncos, Puerto Rico 00777

Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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