Dosage & administration
o
ABSORICA is not substitutable with ABSORICA LD
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
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.
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 |
1Administer in two divided doses with or without meals
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 |
1Administer in two divided doses with or without meals
o
ABSORICA is not substitutable with ABSORICA LD
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
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.
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 |
1Administer in two divided doses with or without meals
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 |
1Administer in two divided doses with or without meals
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Absorica prescribing information
• Pregnancy• Hypersensitivity to this product or any of its components
ABSORICA/ABSORICA LD is contraindicated in pregnancy
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)
ABSORICA/ABSORICA LD is contraindicated in pregnancy
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
There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD therapy 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 .
ABSORICA/ABSORICA LD are contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient. There is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans. If ABSORICA/ABSORICA LD is used during pregnancy, or if the patient becomes pregnant while taking ABSORICA/ABSORICA LD, the patient should be apprised of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking ABSORICA/ABSORICA LD, ABSORICA/ABSORICA LD must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Major congenital malformations that have been documented following isotretinoin exposure include malformations of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. External malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate. Internal abnormalities include: CNS (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency. In some cases, death has occurred as a result of the malformations.
Cases of IQ scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. An increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy.
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
• Prescribers must be certified with the program and comply with the following requirements:
Determine reproductive status of all patients prior to initiating treatmento 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 counselingo 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 requirementso Comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3)]o Demonstrate comprehension of the safe-use conditions of the program every montho 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:
o Only dispense a maximum of a 30-day supply with a Medication Guide.
o Do not dispense refills. Dispense only with a new prescription and a new authorization from the program.
o 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.
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.
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
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
• ABSORICA is not substitutable with ABSORICA LD because of different bioavailability and recommended dosage. (,2.1 Recommended DosageABSORICA is not substitutable with ABSORICA LD
[see Warnings and Precautions (5.3)]. The recommended dosage of:• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
notrecommended.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 BodyWeightTotal Daily Dosage (mg)10.5 mg/kg1 mg/kg2 mg/kg40 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
1Administer in two divided doses with or without meals
Table 2: ABSORICA LD Daily Dosage by Body Weight1BodyWeightTotal Daily Dosage (mg)10.4 mg/kg0.8 mg/kg1.6 mg/kg40 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
1Administer in two divided doses with or without meals
)5.3 ABSORICA and ABSORICA LD are Not SubstitutableGiven that the bioavailability and the recommended dosage of ABSORICA and ABSORICA LD are different, ABSORICA and ABSORICA LD are not substitutable. For example, ABSORICA and ABSORICA LD have a 20 mg strength; however, these strengths have different bioavailability and are not substitutable.
• Recommended dosage for:
o
ABSORICA is not substitutable with ABSORICA LD
• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
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.
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 |
1Administer in two divided doses with or without meals
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 |
1Administer in two divided doses with or without meals
o
ABSORICA is not substitutable with ABSORICA LD
• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
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.
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 |
1Administer in two divided doses with or without meals
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 |
1Administer in two divided doses with or without meals
• Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. ()2.1 Recommended DosageABSORICA is not substitutable with ABSORICA LD
[see Warnings and Precautions (5.3)]. The recommended dosage of:• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
notrecommended.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 BodyWeightTotal Daily Dosage (mg)10.5 mg/kg1 mg/kg2 mg/kg40 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
1Administer in two divided doses with or without meals
Table 2: ABSORICA LD Daily Dosage by Body Weight1BodyWeightTotal Daily Dosage (mg)10.4 mg/kg0.8 mg/kg1.6 mg/kg40 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
1Administer in two divided doses with or without meals
• Once daily dosing isnotrecommended. ()2.1 Recommended DosageABSORICA is not substitutable with ABSORICA LD
[see Warnings and Precautions (5.3)]. The recommended dosage of:• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
notrecommended.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 BodyWeightTotal Daily Dosage (mg)10.5 mg/kg1 mg/kg2 mg/kg40 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
1Administer in two divided doses with or without meals
Table 2: ABSORICA LD Daily Dosage by Body Weight1BodyWeightTotal Daily Dosage (mg)10.4 mg/kg0.8 mg/kg1.6 mg/kg40 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
1Administer in two divided doses with or without meals
• 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. ()2.1 Recommended DosageABSORICA is not substitutable with ABSORICA LD
[see Warnings and Precautions (5.3)]. The recommended dosage of:• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
notrecommended.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 BodyWeightTotal Daily Dosage (mg)10.5 mg/kg1 mg/kg2 mg/kg40 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
1Administer in two divided doses with or without meals
Table 2: ABSORICA LD Daily Dosage by Body Weight1BodyWeightTotal Daily Dosage (mg)10.4 mg/kg0.8 mg/kg1.6 mg/kg40 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
1Administer in two divided doses with or without meals
• Perform pregnancy tests prior to prescribing, each month during therapy, end of therapy, and one month after discontinuation. (,2.3 Laboratory Testing Prior to AdministrationThe 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)].
)8.3 Females and Males of Reproductive PotentialAll patients who can become pregnant must comply with the iPLEDGE program requirements
[see Warnings and Precautions (5.2)].Pregnancy TestingABSORICA/ABSORICA LD must only be prescribed to patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test. Patients who can become pregnant must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial ABSORICA/ABSORICA LD prescription (the interval between the two tests must be at least 19 days).
• The first test (a screening test) is obtained by the prescriber when the decision is made to prescribe ABSORICA/ABSORICA LD therapy.• The second pregnancy test (a confirmation test) is performed after the patient has used 2 forms of contraception for 1 month and during the first 5 days of the menstrual period immediately preceding the beginning of ABSORICA/ABSORICA LD therapy (for patients with regular menstrual cycles) or immediately preceding the beginning of ABSORICA/ABSORICA LD therapy (for patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding).
A pregnancy test must be repeated each month, in a CLIA-certified laboratory prior to the patient receiving each prescription. A pregnancy test must also be completed at the end of the entire course of ABSORICA/ABSORICA LD therapy and 1 month after the discontinuation of ABSORICA/ABSORICA LD.
ContraceptionPatients who can become pregnant must use 2 forms of contraception simultaneously, at least 1 of which must be a primary form, for at least 1 month prior to initiation of ABSORICA/ABSORICA LD therapy, during ABSORICA/ABSORICA LD therapy, and for 1 month after discontinuing ABSORICA/ABSORICA LD therapy. However, 2 forms of contraception is not required if the patient commits to continuous abstinence from not having any sexual contact with a partner which may result in pregnancy, has undergone a hysterectomy or bilateral oophorectomy, or has been medically confirmed to be post-menopausal. Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) are an inadequate method of contraception during ABSORICA/ABSORICA LD therapy.
Primary formsSecondary forms•Tubal sterilization
Barrier:
•Male vasectomy
•male latex condom with or without spermicide
•Intrauterine device
•diaphragm with spermicide
•Hormonal (combination oral contraceptives, vaginal systems, vaginal inserts, transdermal systems, injections, or implants)
•cervical cap with spermicide
Other:
•Vaginal sponge (contains spermicide)
Any birth control method can fail. There have been reports of pregnancy from patients who have used combination oral contraceptives, as well as contraceptive vaginal systems, vaginal inserts, transdermal systems, and injections; these pregnancies occurred while taking isotretinoin. These reports are more frequent for patients who use only a single method of contraception. Therefore, it is critically important that patients who can become pregnant use 2 methods of contraception simultaneously.
A clinical drug interaction study did not show any clinically significant interaction between isotretinoin and norethindrone and ethinyl estradiol; however, it is not known if there is an interaction between isotretinoin with other progestins
[seeDrug Interactions (7.5)].Prescribers are advised to consult the prescribing information of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.Patients who can become pregnant should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because of a possible interaction with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.
If the patient has unprotected sexual contact with a partner that could result in pregnancy at any time 1 month before, during, or 1 month after therapy, the patient must:
1.000000000000000e+00 Stop taking ABSORICA/ABSORICA LD immediately, if on therapy2.000000000000000e+00 Have a pregnancy test at least 19 days after the last act of unprotected sexual contact with a partner that could result in pregnancy3.000000000000000e+00 Start using 2 forms of contraception simultaneously again for 1 month before resuming ABSORICA/ABSORICA LD therapy4.000000000000000e+00 Have a second pregnancy test after using 2 forms of contraception for 1 month.
InfertilityIn a trial of female acne patients (n = 79) receiving another isotretinoin capsule product, the mean total ovarian volume, the total antral follicle count and mean anti-Mullerian hormone decreased at the end of the treatment (sixth month). However, the values returned to normal at the 18thmonth (12 months after the end of treatment). There were no statistically significant changes in terms of follicle-stimulating hormone and luteinizing hormone, both at the end of the treatment and 12 months after the end of treatment. Although the results suggest that possible deteriorative effects of isotretinoin on ovarian reserve may be reversible, the study has important methodological limitations, including a small sample size, lack of a control group, and lack of generalizability.
Sperm StudyIn trials of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving isotretinoin therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
• Prior to prescribing, perform fasting lipid profile and liver function tests. ()2.3 Laboratory Testing Prior to AdministrationThe 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)].
ABSORICA and ABSORICA LD have different dosage regimens
ABSORICA is not substitutable with ABSORICA LD
• ABSORICA is 0.5 to 1 mg/kg/daygiven 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/daygiven 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
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.
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 |
1Administer in two divided doses with or without meals
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 |
1Administer in two divided doses with or without meals
• 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”).
Lactation: Breastfeeding not recommended
There are no data on the presence of isotretinoin in either animal or human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in nursing infants from isotretinoin, advise patients that breastfeeding is not recommended during treatment with ABSORICA/ABSORICA LD, and for at least 8 days after the last dose of ABSORICA/ABSORICA LD.
• Pregnancy (,4.1 PregnancyABSORICA/ABSORICA LD is contraindicated in pregnancy
[see Warnings and Precautions (5.1)and Use in Specific Populations (8.1)].)8.1 PregnancyPregnancy Exposure RegistryThere is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to isotretinoin during pregnancy. Report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD therapy 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 .
Risk SummaryABSORICA/ABSORICA LD are contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient. There is an increased risk of major congenital malformations, spontaneous abortions, and premature births following isotretinoin exposure during pregnancy in humans. If ABSORICA/ABSORICA LD is used during pregnancy, or if the patient becomes pregnant while taking ABSORICA/ABSORICA LD, the patient should be apprised of the potential hazard to a fetus. If pregnancy occurs during treatment of a patient who is taking ABSORICA/ABSORICA LD, ABSORICA/ABSORICA LD must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
DataHuman DataMajor congenital malformations that have been documented following isotretinoin exposure include malformations of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. External malformations include: skull; ear (including anotia, micropinna, small or absent external auditory canals); eye (including microphthalmia); facial dysmorphia and cleft palate. Internal abnormalities include: CNS (including cerebral and cerebellar malformations, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular; thymus gland; parathyroid hormone deficiency. In some cases, death has occurred as a result of the malformations.
Cases of IQ scores less than 85 with or without other abnormalities have been reported in children exposed in utero to isotretinoin. An increased risk of spontaneous abortion and premature births have been reported with isotretinoin exposure during pregnancy.
• Hypersensitivity to this product or any of its components (,4.2 HypersensitivityABSORICA/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)].)5.14 Hypersensitivity ReactionsAnaphylactic reactions and other allergic reactions have been reported with isotretinoin use. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement (including renal) have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.
Allergic Reactions Due to the Inactive Ingredient (FD&C Yellow No. 5) in the 25 mg ABSORICA CapsuleThe 25 mg ABSORICA capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of tartrazine sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. The 10 mg, 20 mg, 30 mg, 35 mg, and 40 mg ABSORICA capsules do not contain FD&C Yellow No. 5 and all of the ABSORICA LD capsules do not contain FD&C Yellow No. 5. Thus, in patients with allergic reactions to tartrazine, avoid using the 25 mg ABSORICA capsules.