isotretinoin

eye-soe-TRET-i-noyn

Therapeutic Classification: antiacne agents

Pharmacologic Classification: retinoids

REMS

Severe recalcitrant nodular acne in patients with multiple inflammatory nodules having a diameter of ≥5 mm and that are unresponsive to more conventional therapy, including systemic antibiotics.

A metabolite of vitamin A (retinol); reduces sebaceous gland size and differentiation.

Therapeutic effects:

Diminution and resolution of severe acne. May also prevent abnormal keratinization.

Absorption: Rapidly absorbed following (23–25%) oral administration (bioavailability of Absorica LD higher than that of Absorica); absorption ↑ when taken with a high-fat meal.

Distribution: Appears to be widely distributed.

Protein Binding: 99.9%.

Metabolism/Excretion: Metabolized by the liver and excreted in the urine and feces.

Half-Life: 10–20 hr.

(diminution of acne)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	up to 8 wk	unknown

Contraindicated in:

Hypersensitivity to retinoids, glycerin, soybean oil, or parabens;
Patients planning to donate blood;
OB: Pregnancy;
Lactation: Lactation;
Rep: Women of childbearing age who may become or who intend to become pregnant;

Use Cautiously in:

Pre-existing hypertriglyceridemia;
Diabetes mellitus;
History of alcohol abuse, psychosis, depression, or suicide attempt;
Obese patients;
Inflammatory bowel disease;
Pedi: Children <12 yr (safety and effectiveness not established).

CV: edema

Derm: pruritus, palmar desquamation, photosensitivity, skin infections, STEVENS-JOHNSON SYNDROME (SJS), thinning of hair, TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: conjunctivitis, epistaxis, ↓night vision, blurred vision, contact lens intolerance, corneal opacities, dry eyes

Endo: hyperglycemia

F and E: ↑thirst

GI: cheilitis, dry mouth, nausea, vomiting, abdominal pain, anorexia, hepatitis, pancreatitis

Hemat: anemia

Metab: ↓high-density lipoprotein cholesterol (HDL-C), hypercholesterolemia, hypertriglyceridemia, ↑appetite, hyperuricemia

MS: arthralgia, back pain, muscle/bone pain (↑ in adolescents), hyperostosis

Neuro: behavior changes, depression, PSEUDOTUMOR CEREBRI, psychosis, SUICIDAL THOUGHTS/BEHAVIORS

Drug-drug:

Additive toxicity with vitamin A and drugs having anticholinergic properties.
↑risk of pseudotumor cerebri with tetracycline or minocycline.
Concurrent use with alcohol↑ risk of hypertriglyceridemia.
Drying effects ↑ by concurrent use of benzoyl peroxide, sulfur, tretinoin, and other topical agents.

Drug-Food:

Excessive ingestion of foods high in vitamin A may result in additive toxicity.

Absorica and Absorica LD are not interchangeable.
PO (Adults and Children ≥12 yr): 0.5–1 mg/kg/day (may use up to 2 mg/kg/day for very severe disease) in 2 divided doses for 15–20 wk. Once discontinued, if relapse occurs, therapy may be reinstituted after an 8-wk rest period. Absorica LD: 0.4–0.8 mg/kg/day (may use up to 1.6 mg/kg/day for very severe disease) in 2 divided doses for 15–20 wk. Once discontinued, if relapse occurs, therapy may be reinstituted after an 8-wk rest period.

(Generic available)

Capsules: 10 mg; 20 mg; 25 mg; 30 mg; 35 mg; 40 mg
Capsules (Absorica LD): 8 mg; 16 mg; 24 mg; 32 mg

REMS: Verify that patient receiving isotretinoin is registered with the iPLEDGE REMS and is completing all required interactions with their health care provider.
Assess skin prior to and periodically during therapy. Transient worsening of acne may occur at initiation of therapy. Note number and severity of cysts, degree of skin dryness, erythema, and itching.
Assess for allergy to parabens; capsules contain parabens as a preservative.
Monitor patient for behavioral changes throughout therapy. May cause depression, psychosis, and suicide ideation. If behavioral changes occur, they usually resolve with discontinuation of therapy.
Assess for rash periodically during therapy. May cause SJS or TEN. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.

Lab Test Considerations:

Verify two negative sequential serum or urine pregnancy tests with a sensitivity ≥25 mIU/mL before receiving initial prescription and monthly before each new Rx.
- Monitor liver function (AST, ALT, and LDH) prior to therapy, after 1 mo of therapy, and periodically thereafter. Inform health care professional if these values become ↑ therapy; may need to be discontinued.
- Monitor blood lipids (cholesterol, HDL-C, triglycerides) under fasting conditions prior to beginning therapy, at 1–2 wk intervals until lipid response to isotretinoin is established (usually within 1 mo), and periodically thereafter. Report ↑ cholesterol and triglyceride levels or ↓ HDL-C.
- Obtain baseline and periodic CBC, urinalysis, and metabolic panel. May cause ↑ blood glucose, CK, platelet counts, and sedimentation rate. May ↓ RBC and WBC parameters. May cause proteinuria, RBCs and WBCs in urine, and ↑ uric acid.

Do not confuse isotretinoin with tretinoin.
REMS: Isotretinoin is approved for marketing only under the iPLEDGE REMS, a special restricted distribution program approved by the FDA.
REMS: Only patients who meet all requirements of the iPLEDGE REMS may receive isotretinoin.
REMS: Isotretinoin may only be prescribed by health care providers registered and activated with the iPLEDGE REMS.
REMS: Isotretinoin may only be dispensed by pharmacies registered with the iPLEDGE REMS.
PO: Administer without regard to meals. Administer with a full glass of liquid to decrease the risk of esophageal irritation. DNC: Do not crush or open capsules.

REMS: Explain the iPLEDGE REMS and its requirements to patient and parent.
Instruct patient to take isotretinoin as directed. Do not take more than the amount prescribed. If a dose is missed omit dose; do not double doses. Patients must read Medication Guide and sign consent form prior to initiation of therapy.
Explain to patient that a temporary worsening of acne may occur at beginning of therapy.
Advise patient and family to notify health care professional if rash or thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood occur.
May cause sudden decrease in night vision. Caution patient to avoid driving at night until response to the medication is known.
Advise patient to consult with health care professional before using other acne preparations while taking isotretinoin. Soaps, cosmetics, and shaving lotion may also worsen dry skin.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
Instruct patient not to take vitamin A supplements and to avoid excessive ingestion of foods high in vitamin A (liver; fish liver oils; egg yolks; yellow-orange fruits and vegetables; dark green, leafy vegetables; whole milk; vitamin A–fortified skim milk; butter; margarine) while taking isotretinoin; this may result in hypervitaminosis.
Advise patient to avoid alcoholic beverages while taking isotretinoin, as this may further increase triglyceride levels.
Inform patient that dry skin and chapped lips will occur. Lubricant to lips may help cheilitis.
Instruct patient that oral rinses, good oral hygiene, and sugarless gum or candy may help minimize dry mouth. Notify health care professional if dry mouth persists for more than 2 wk.
Discuss possibility of excessively dry eyes with patients who wear contact lenses. Patient should contact health care professional about eye lubricant. Patient may need to switch to glasses during course of therapy and for up to 2 wk following discontinuation.
Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions. Consult health care professional about sunscreen, as some sunscreens may worsen acne.
Inform diabetic patients that difficulty controlling blood glucose may occur.
Instruct patient to report burning of eyes, visual changes, rash, abdominal pain, diarrhea, headache, nausea, and vomiting to health care professional.
Advise patient not to donate blood while receiving this medication. After discontinuing isotretinoin, wait at least 1 mo before donating blood to prevent the possibility of a pregnant patient receiving the blood.
Rep: May cause fetal harm. Instruct female patients of reproductive potential to use 2 forms of contraception 1 mo before therapy, during therapy, and for at least 1 mo after discontinuation of isotretinoin. Patient who can become pregnant must have 2 negative serum or urine pregnancy tests with a sensitivity ≥25 mIU/mL before receiving initial prescription. First test is obtained by prescriber when decision is made to prescribe isotretinoin. Second pregnancy test should be done after patient has used 2 forms of contraception for 1 mo and during first 5 days of menstrual period immediately preceding beginning of therapy. For patients with amenorrhea, second test should be done 11 days after last act of unprotected sexual intercourse. Each mo of therapy patient must have a negative result from a urine or serum pregnancy test. Pregnancy test must be repeated every mo prior to receiving prescription in patients who can become pregnant. Patient should discontinue medication and inform health care professional immediately if pregnancy is suspected during or 1 month after therapy. If pregnancy occurs, 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). Recommended consent form prepared by manufacturer stresses fetal risk. Parents of minors should also read and sign form. Yellow self-adhesive qualification stickers completed by prescriber must accompany prescription. Advise patient to avoid breastfeeding during and for at least 8 days after last dose.
Inform patient of need for medical follow-up. Periodic lab tests may be required.

Decrease in the number and severity of cysts in severe acne. Therapy may take 4–5 mo before full effects are seen. Therapy is discontinued when the number of cysts is reduced by 70% or after 5 mo. Improvement may occur after discontinuation of therapy; therefore, a delay of at least 8 wk is recommended before a second course of therapy is considered.

Absorica, Absorica LD, Accutane, Amnesteem, Claravis, Myorisan, Zenatane

Clarus, Epuris

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-6611- Amnesteem
  - 0378-6611-93- 3 BLISTER PACK in 1 CARTON (0378-6611-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6611-85)

0378- Mylan Pharmaceuticals Inc.
- 0378-6612- Amnesteem
  - 0378-6612-93- 3 BLISTER PACK in 1 CARTON (0378-6612-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)

0378- Mylan Pharmaceuticals Inc.
- 0378-6614- Amnesteem
  - 0378-6614-93- 3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1054- Claravis
  - 0555-1054-56- 10 BLISTER PACK in 1 CARTON (0555-1054-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1054- Claravis
  - 0555-1054-86- 3 BLISTER PACK in 1 CARTON (0555-1054-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1055- Claravis
  - 0555-1055-56- 10 BLISTER PACK in 1 CARTON (0555-1055-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1055- Claravis
  - 0555-1055-86- 3 BLISTER PACK in 1 CARTON (0555-1055-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1056- Claravis
  - 0555-1056-86- 3 BLISTER PACK in 1 CARTON (0555-1056-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1056-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1057- Claravis
  - 0555-1057-56- 10 BLISTER PACK in 1 CARTON (0555-1057-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-1057- Claravis
  - 0555-1057-86- 3 BLISTER PACK in 1 CARTON (0555-1057-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-002- Absorica LD
  - 10631-002-31- 3 BLISTER PACK in 1 BOX (10631-002-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-003- Absorica LD
  - 10631-003-31- 3 BLISTER PACK in 1 BOX (10631-003-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-004- Absorica LD
  - 10631-004-31- 3 BLISTER PACK in 1 BOX (10631-004-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-005- Absorica LD
  - 10631-005-31- 3 BLISTER PACK in 1 BOX (10631-005-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-006- Absorica LD
  - 10631-006-31- 3 BLISTER PACK in 1 BOX (10631-006-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-007- Absorica LD
  - 10631-007-31- 3 BLISTER PACK in 1 BOX (10631-007-31) > 10 CAPSULE in 1 BLISTER PACK

10631- Sun Pharmaceutical Industries, Inc.
- 10631-115- Absorica
  - 10631-115-31- 3 BLISTER PACK in 1 BOX (10631-115-31) > 10 CAPSULE in 1 BLISTER PACK (10631-115-69)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-116- Absorica
  - 10631-116-31- 3 BLISTER PACK in 1 BOX (10631-116-31) > 10 CAPSULE in 1 BLISTER PACK (10631-116-69)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-117- Absorica
  - 10631-117-31- 3 BLISTER PACK in 1 BOX (10631-117-31) > 10 CAPSULE in 1 BLISTER PACK (10631-117-69)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-118- Absorica
  - 10631-118-31- 3 BLISTER PACK in 1 BOX (10631-118-31) > 10 CAPSULE in 1 BLISTER PACK (10631-118-69)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-133- Absorica
  - 10631-133-31- 3 BLISTER PACK in 1 BOX (10631-133-31) > 10 CAPSULE in 1 BLISTER PACK (10631-133-69)

10631- Sun Pharmaceutical Industries, Inc.
- 10631-134- Absorica
  - 10631-134-31- 3 BLISTER PACK in 1 BOX (10631-134-31) > 10 CAPSULE in 1 BLISTER PACK (10631-134-69)

55111- Dr. Reddy's Laboratories Limited
- 55111-113- ZENATANE
  - 55111-113-78- 10 BLISTER PACK in 1 CARTON (55111-113-78) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

55111- Dr. Reddy's Laboratories Limited
- 55111-113- ZENATANE
  - 55111-113-81- 3 BLISTER PACK in 1 CARTON (55111-113-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79)

55111- Dr. Reddy's Laboratories Limited
- 55111-135- ZENATANE
  - 55111-135-81- 3 BLISTER PACK in 1 CARTON (55111-135-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-135-79)

55111- Dr. Reddy's Laboratories Limited
- 55111-136- ZENATANE
  - 55111-136-81- 3 BLISTER PACK in 1 CARTON (55111-136-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-136-79)

55111- Dr. Reddy's Laboratories Limited
- 55111-137- ZENATANE
  - 55111-137-81- 3 BLISTER PACK in 1 CARTON (55111-137-81) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-137-79)

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-301- Myorisan
  - 61748-301-01- 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-301-01)

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-301- Myorisan
  - 61748-301-11- 10 BLISTER PACK in 1 CARTON (61748-301-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-301- Myorisan
  - 61748-301-13- 3 BLISTER PACK in 1 CARTON (61748-301-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-302- Myorisan
  - 61748-302-01- 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-302-01)

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-302- Myorisan
  - 61748-302-11- 10 BLISTER PACK in 1 CARTON (61748-302-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-302- Myorisan
  - 61748-302-13- 3 BLISTER PACK in 1 CARTON (61748-302-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-303- Myorisan
  - 61748-303-01- 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-303-01)

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-303- Myorisan
  - 61748-303-11- 10 BLISTER PACK in 1 CARTON (61748-303-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-303- Myorisan
  - 61748-303-13- 3 BLISTER PACK in 1 CARTON (61748-303-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-304- Myorisan
  - 61748-304-01- 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-304-01)

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-304- Myorisan
  - 61748-304-11- 10 BLISTER PACK in 1 CARTON (61748-304-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

61748- VersaPharm, Inc. ñ An Akorn Company
- 61748-304- Myorisan
  - 61748-304-13- 3 BLISTER PACK in 1 CARTON (61748-304-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

69238- Amneal Pharmaceuticals NY LLC
- 69238-1017- Isotretinoin
  - 69238-1017-3- 3 BLISTER PACK in 1 CARTON (69238-1017-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1174- Isotretinoin
  - 69238-1174-3- 3 BLISTER PACK in 1 CARTON (69238-1174-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1174-1)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1175- Isotretinoin
  - 69238-1175-3- 3 BLISTER PACK in 1 CARTON (69238-1175-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1175-1)

69238- Amneal Pharmaceuticals NY LLC
- 69238-1176- Isotretinoin
  - 69238-1176-3- 3 BLISTER PACK in 1 CARTON (69238-1176-3) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1176-1)

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