Absorica

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

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

ABSORICA/ABSORICA LD can cause severe life-threatening birth defects and is contraindicated in pregnancy.

There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue ABSORICA/ABSORICA LD immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].

Because of the risk of embryo-fetal toxicity, ABSORICA and ABSORICA LD are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2)].

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:

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

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)].

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