Isotretinoin

ISOTRETINOIN- isotretinoin capsule
Actavis Pharma, Inc.

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

Isotretinoin capsules 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 isotretinoin capsules 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 isotretinoin capsules 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, isotretinoin capsules 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

Isotretinoin capsules 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, isotretinoin capsules 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 isotretinoin capsules 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

The recommended dosage of isotretinoin capsules 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).

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 isotretinoin capsules in divided doses, as tolerated.

The safety and effectiveness of once daily dosing with isotretinoin capsules has not been established and is not recommended.

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

Table 1: Isotretinoin Capsules 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

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 isotretinoin capsules.

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 isotretinoin capsules in patients who have completed skeletal growth. The use of another course of isotretinoin capsules 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 isotretinoin capsules, even in low dosages, has not been studied, and is not recommended. The effect of long-term use of isotretinoin capsules 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 isotretinoin capsules use:

  • Pregnancy testing: Ensure patient is not pregnant prior to administering isotretinoin capsules [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)].

3 DOSAGE FORMS AND STRENGTHS

Isotretinoin capsules, USP are available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.

  • 10 mg capsules: White opaque/white opaque size 1 capsules imprinted with WPI and 2433 in black ink and filled with a yellow semi-solid and banded with a blue band.
  • 20 mg capsules: White opaque/light yellow opaque size 0 capsules imprinted with WPI and 2434 in black ink and filled with a yellow semi-solid and banded with a blue band.
  • 25 mg capsules: Light green opaque/light green opaque size 0 capsules imprinted with WPI and A128 in black ink and filled with a yellow semi-solid and banded with a blue band.
  • 30 mg capsules: Orange opaque/orange opaque size 00 capsules imprinted with WPI and 2435 in black ink and filled with a yellow semi-solid and banded with a blue band.
  • 35 mg capsules: Flesh opaque/flesh opaque size 00 capsules imprinted with WPI and A168 in black ink and filled with a yellow semi-solid and banded with a blue band.
  • 40 mg capsules: Orange opaque/orange opaque size 00 capsules imprinted with WPI and 2436 in black ink and filled with a yellow semi-solid and banded with a blue band.

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