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trientine (Syprine)

 

Classes: Copper Chelators

Dosing and uses of Syprine (trientine)

 

Adult dosage forms and strengths

capsule

  • 250mg

 

Wilson Disease

For patients intolerant of penicillamine

750-1250 mg/day PO divided q6-12hr; not to exceed 2 g/day

 

Manganism (Orphan)

Indicated for the treatment of manganism

Orphan indication sponsor

  • Biovail Technologies, Ltd; 700 Route 202/206 North; Bridgewater, NJ 08807

 

Wilson Disease (Orphan)

New salt form: trientine tetrahydrochloride

Orphan designation for treatment of Wilson Disease

Sponsor

  • GMP-Orphan SAS; Voisin Consulting, Inc; 222 Third Street, Suite 3121; Cambridge, Massachusetts 02142

 

Pediatric dosage forms and strengths

capsule

  • 250mg

 

Wilson Disease

<12 years

  • 500-750 mg/day PO divided q6-12hr; not to exceed 1.5 g/day

≥12 years

  • For patients intolerant of penicillamine: 750-1250 mg/day PO divided q6-12hr; not to exceed 2 g/day

 

Syprine (trientine) adverse (side) effects

Frequency not defined

Dystonia

Iron deficiency

Rash; thickening and fissuring of skin

Muscular spasm

Myasthenia gravis

SLe

Abdominal pain

Gastritis

Aphthoid ulcer

Anorexia

Colitis

Heartburn

Loss of taste

Aplastic anemia

Sideroblastic anemia

Lupus like eruption

Myasthenia gravis

 

Warnings

Contraindications

Hypersensitivity to product or components

 

Cautions

Not indicated for cystinuria, RA (cf penicillamine) or biliary cirrhosis

May cause iron deficiency anemia

Hepatic iron oveload may result from copper deficiency induced by therapy

Monitor urinary copper and for signs of hypersensitivity (eg, elevated body temperature)

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Excretioin in breast milk unknown; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Syprine (trientine)

Mechanism of action

Oral chelating agent used to induce adequate cupriuresis

 

Pharmacokinetics

Absorption: Poor

Excretion: Urine (9%)

Metabolite: Acetyltrien

 

Administration

Oral Administration

Take on empty stomach 1 hr before or 2 hr after meals