ABSORICA Capsule Ref.[50736] Active ingredients: Isotretinoin

2.1 Recommended Dosage

ABSORICA is not substitutable with ABSORICA LD [see Warnings and Precautions (5.3)]. The recommended dosage of:

• ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 1).
• ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 2).

To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. During treatment, the dosage may be adjusted according to response of the disease and/or adverse reactions, 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 dosage adjustments up to 2 mg/kg/day for ABSORICA (1.6 mg/kg/day for ABSORICA LD) in divided doses, as tolerated.

The safety and effectiveness of once daily dosing with ABSORICA/ABSORICA LD has not been established and is not recommended.

If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ ABSORICA LD at the same time.

Table 1. ABSORICA Daily Dosage by Body Weight¹:

¹ Administer in two divided doses with or without meals

Table 2. ABSORICA LD Daily Dosage by Body Weight¹:

¹ Administer in two divided doses with or without meals

2.2 Duration of Use

A normal course of treatment is 15 to 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, may discontinue ABSORICA/ABSORICA LD.

After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, may initiate a second course of ABSORICA/ABSORICA LD in patients who have completed skeletal growth. The use of another course of ABSORICA/ABSORICA LD therapy is not recommended before a two-month waiting period because the patient’s acne may continue to improve after a 15 to 20-week course of therapy. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.

Long-term use of ABSORICA/ABSORICA LD, even in low dosages, has not been studied, and is not recommended. The effect of long-term use of ABSORICA/ABSORICA LD on bone loss is unknown [see Warnings and Precautions (5.12)].

2.3 Laboratory Testing Prior to Administration

The following laboratory testing must be completed prior to ABSORICA/ABSORICA LD use:

• Pregnancy testing: Ensure patient is not pregnant prior to administering ABSORICA/ABSORICA LD [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)]
• A fasting lipid profile including triglycerides [see Warnings and Precautions (5.8, 5.15)].
• Liver function tests [see Warnings and Precautions (5.10, 5.15)].

In humans, isotretinoin overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolved without apparent residual effects.

Patients who can become pregnant who present with an ABSORICA/ABSORICA LD overdosage should be evaluated for pregnancy. Because an overdosage would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients treated with ABSORICA/ABSORICA LD should use a condom, or avoid reproductive sexual activity with a patient who is or might become pregnant, for 1 month after the overdose.

All patients with ABSORICA/ABSORICA LD overdose should not donate blood for at least 1 month.

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