Prescription Drug Information: Absorica

ABSORICA- isotretinoin capsule
ABSORICA LD- isotretinoin capsule
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.

Limitations of Use:

If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

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

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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).

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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

Body Weight	Total Daily Dosage (mg)1
	0.5 mg/kg	1 mg/kg	2 mg/kg
40 kg	20	40	80
50 kg	25	50	100
60 kg	30	60	120
70 kg	35	70	140
80 kg	40	80	160
90 kg	45	90	180
100 kg	50	100	200

¹ Administer in two divided doses with or without meals

Table 2: ABSORICA LD Daily Dosage by Body Weight¹

Body Weight	Total Daily Dosage (mg)1
	0.4 mg/kg	0.8 mg/kg	1.6 mg/kg
40 kg	16	32	64
50 kg	20	40	80
60 kg	24	48	96
70 kg	28	56	112
80 kg	32	64	128
90 kg	36	72	144
100 kg	40	80	160

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:

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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)]

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A fasting lipid profile including triglycerides [see Warnings and Precautions (5.8, 5.15)].

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Liver function tests [see Warnings and Precautions (5.10, 5.15)].

3 DOSAGE FORMS AND STRENGTHS

ABSORICA and ABSORICA LD have different dosage regimens [see Dosage and Administration (2.1)]. Although ABSORICA and ABSORICA LD have a 20 mg strength, these strengths have different bioavailability and are not substitutable.

ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.

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10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240 ” on cap and “10 ” on the body

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20 mg: Red, opaque, capsule imprinted with black ink “G 241 ” on cap and “20 ” on the body

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25 mg: Green, opaque, capsule imprinted with white ink “G 342 ” on cap and “25 ” on the body

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30 mg: Brown, opaque, capsule imprinted with white ink “G 242 ” on cap and “30 ” on the body

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35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343 ” on cap and “35 ” on the body

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40 mg: Brown and red, capsule imprinted with white ink “G 325 ” on cap and “40 ” on the body

ABSORICA LD is available in 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg opaque-printed, hard-gelatin capsules.

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8 mg: A size 3, light green with a colorless band (the cap is printed in white with “RL29” and the body is printed in white with “RL29 ”).

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16 mg: A size 2, dark blue with a colorless band (the cap is printed in white with “RL30” and the body is printed in white with “RL30 ”).

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20 mg: A size 1, dark pink with a colorless band (the cap is printed in black with “RL33”and the body is printed in black with “RL33 ”).

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24 mg: A size 1, yellow with a colorless band (the cap is printed in white with “RL31” and the body is printed in white with “RL31 ”).

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28 mg: A size 0, light blue, with a colorless band (the cap is printed in black with “RL34” and the body is printed in black with “RL34 ”).

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32 mg: A size 0, caramel with a colorless band (the cap is printed in white with “RL32” and the body is printed in white with “RL32 ”).