Users

Isotretinoin Monitoring

Affected Drug

• D10BA01 Isotretinoin

Baseline

Baseline: CBC, AST, ALT, fasting lipid profile, pregnancy test x 2

Follow-up

Follow-up: Q monthly CBC, AST, ALT, fasting lipid profile, pregnancy test

Important Interactions

• Drugs: tetracycline
  Interaction can increase incidence of pseudotumor cerebri
• Drugs: ethanol
  Interaction Avoid/limit EtOH (risk of hypertriglyceridemia)

Details

Conditions	System	Monitoring		ADE	Incidence	Recommendation
		Baseline	Follow-up
	derm	Physical Exam	PRN for signs/symptoms	photosensitivity;	common	Avoid sunlight, use sunscreen
				dry skin/mucous membranes	common	Dose related, start 0.5 mg/kg/d x 1 mo then 1 mg/kg/d for remainder to avoid, topical emollients
Sex -- Not All: female	Reproductive	Two negative preg tests (blood or urine)	Q monthly preg test for duration of tx	spontaneous abortion;	20 %;	Female pts need 2 forms of birth control to start 1 mo prior to tx until 1 mo post-tx See iPLEDGE program
				severe, life threatening, congenital malformations	20-30% of pregnancies that progress	Female pts need 2 forms of birth control to start 1 mo prior to tx until 1 mo post-tx See iPLEDGE program
	Hepatic	AST, ALT	AST, ALT q monthly	elevated serum transaminases;	Incr AST/ALT 15%	D/C or decrease dose if AST, ALT >3x ULN;
				hepatitis	rare	D/C if hepatitis suspected
	Endocrine	Fasting lipid profile	Fasting lipid profile qmonthly	incr triglycerides	25%	Transient, resolves w d/c tx; d/c if TG>9 as incr risk of acute pancreatitis
				incr total, ldl chol	30%	Transient, resolves w d/c tx;
	Hematol	CBC	CBC qmonthly	anemia, neutropenia, thrombocytopenia, agranulocytosis	rare	Experts recommend monitoring; product manufacturer does not support
	CNS	History & physical	PRN for signs/sx	pseudotumor cerebri	rare	Avoid concomitant use w/ tetracyclines
				depression, suicide (controversial, not supported in clinical trials)	rare	Counsel re: possible worsening of depressive sx

References

• Ofori AO. Oral isotretinoin therapy for acne vulgaris. In: UpToDate, Basow, DS (Ed) UpToDate, Waltham, MA, 2010.
• Gray J, editor. Therapeutic Choices, 5th edition. Ottawa: The Canadian Pharmacists Association; 2007.
• Repchinsky C, editor. Compendium of Pharmaceutical and Specialties, 2012 edition. Ottawa: The Canadian Pharmacists Association; 2012.;
• Goodfield et al. Advice on the safe introduction and continued use of isotretinoin in acne in the UK. Br J Dermatol. 2010:162;1172-79.