Absorica: Package Insert and Label Information

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)].

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)].

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.

10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240 ” on cap and “10 ” on the body
20 mg: Red, opaque, capsule imprinted with black ink “G 241 ” on cap and “20 ” on the body
25 mg: Green, opaque, capsule imprinted with white ink “G 342 ” on cap and “25 ” on the body
30 mg: Brown, opaque, capsule imprinted with white ink “G 242 ” on cap and “30 ” on the body
35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343 ” on cap and “35 ” on the body
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.

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 ”).
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 ”).
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 ”).
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 ”).
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 ”).
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 ”).

4 CONTRAINDICATIONS

4.1 Pregnancy

ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

4.2 Hypersensitivity

ABSORICA/ABSORICA LD is contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

ABSORICA/ABSORICA LD is contraindicated in pregnancy [see Contraindications (4.1)]. Based on human data, ABSORICA/ABSORICA LD can cause fetal harm when administered to a pregnant patient. 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. Major congenital malformations, spontaneous abortions, and premature births have been documented following exposure to isotretinoin during pregnancy [see Use in Specific Populations (8.1)].

If a pregnancy occurs during ABSORICA/ABSORICA LD treatment, discontinue ABSORICA/ABSORICA LD immediately and refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD therapy must be reported immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088, and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com).

Patients must be informed not to donate blood during ABSORICA/ABSORICA LD therapy and for 1 month following discontinuation because the blood might be given to a pregnant patient whose fetus must not be exposed to isotretinoin.

ABSORICA/ABSORICA LD is available only through a restricted program under a REMS [see Warnings and Precautions (5.2)].

5.2 iPLEDGE Program

ABSORICA/ABSORICA LD are available only through a restricted program under a REMS called the iPLEDGE REMS because of the risk of embryo-fetal toxicity [see Warnings and Precautions (5.1)]. Notable requirements of the iPLEDGE REMS include the following:

Prescribers must be certified with the program and comply with the following requirements:
Determine reproductive status of all patients prior to initiating treatment
Provide contraception counseling to patients who can get pregnant prior to and during treatment, or refer patients who can get pregnant to an expert for such counseling
Provide scheduled pregnancy testing, and verify and document the negative pregnancy test result prior to writing each prescription, for no more than a 30-day supply
Patients who can become pregnant must be enrolled by signing an informed consent form and must comply with the following requirements
Comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3)]
Demonstrate comprehension of the safe-use conditions of the program every month
Obtain the prescription within 7 days of the pregnancy test collection
Patients who cannot become pregnant must be enrolled by signing an informed consent form and must obtain the prescription within 30 days of the office visit
Pharmacies that dispense ABSORICA/ABSORICA LD must be certified by being registered and activated in the program, must only dispense to patients who are authorized to receive ABSORICA/ABSORICA LD, and comply with the following requirements:
Only dispense a maximum of a 30-day supply with a Medication Guide.
Do not dispense refills. Dispense only with a new prescription and a new authorization from the program.
Return ABSORICA/ABSORICA LD to inventory if patients do not obtain the prescription by the “Do Not Dispense To After ” date
Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies.

Further information, including a list of qualified pharmacies and distributors, is available at www.ipledgeprogram.com or 1-866-495-0654.

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