Trientine is a chelating (KEE-late-ing) agent. A chelating agent works by removing a heavy metal (such as lead, mercury, or copper) from the blood.

Wilson's disease is a genetic metabolic defect that causes excess copper to build up in the body.

Trientine is used to treat this inherited condition in people who cannot take penicillamine.

Trientine may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not take trientine in larger or smaller amounts or for longer than recommended.

Take trientine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not drink milk, eat food, or take any other medications for at least 1 hour after you take trientine.

Do not chew, break, or open a trientine capsule. Swallow it whole.

The medicine from a broken pill can be irritating if it gets on your skin. If this occurs, wash your skin with water right away. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Your doctor may have you take extra iron while you are taking trientine. Take only the amount of iron that your doctor has prescribed.

Call your doctor if you have a fever or a skin rash while taking this medicine. You may need to take your temperature every night for the first month of treatment with trientine.

While using trientine, you may need frequent blood and urine tests. You should remain under the care of a doctor during treatment.

Store in the refrigerator, do not freeze. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Wilson's Disease:

750 to 1250 mg, orally, in divided doses given 2, 3, or 4 times daily
Maximum dose: 2000 mg daily

Comments:
-Increase dose for inadequate clinical response or free serum copper persistently above 20 mcg/dL.
-Re-evaluate dose every 6 to 12 months.
-Clinical experience with this drug is limited and alternate dosing regimens have not been well characterized.
-All dosing endpoints are not well defined.
-This drug is not interchangeable with penicillamine.
-Use this drug when penicillamine treatment is not possible because of intolerable or life threatening side effects.
-This drug is not recommended for cystinuria or rheumatoid arthritis.
-It is incapable of binding cystine, so it is of no use in cystinuria.
-In a small study, it was ineffective for rheumatoid arthritis.
-This drug is not indicated for treatment of biliary cirrhosis.

Use: Treatment of Wilson's disease in patients who are intolerant of penicillamine.

Usual Pediatric Dose for Wilson's Disease:

13 and older:
750 to 1250 mg, orally, in divided doses given 2, 3, or 4 times daily
Maximum dose: 2000 mg daily

12 and under:
500 to 750 mg, orally, in divided doses given 2, 3, or 4 times daily
Maximum dose: 1500 mg daily

Comments:
-Increase dose for inadequate clinical response or free serum copper persistently above 20 mcg/dL.
-Re-evaluate dose every 6 to 12 months.
-Clinical experience with this drug is limited and alternate dosing regimens have not been well characterized.
-All dosing endpoints are not well defined.
-This drug is not interchangeable with penicillamine.
-Use this drug when penicillamine treatment is not possible because of intolerable or life threatening side effects.
-This drug is not recommended for cystinuria or rheumatoid arthritis.
-It is incapable of binding cystine, so it is of no use in cystinuria.
-In a small study, it was ineffective for rheumatoid arthritis.
-This drug is not indicated for treatment of biliary cirrhosis.

Use: Treatment of Wilson's disease in patients who are intolerant of penicillamine.

You should not use this medication if you are allergic to trientine.

To make sure trientine is safe for you, tell your doctor if you have:

• anemia (low red blood cells); or

• a liver condition called biliary cirrhosis.

FDA pregnancy category C. It is not known whether trientine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether trientine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ask your doctor before using a vitamin or mineral supplement, and use only the type your doctor recommends. Some minerals can make it harder for your body to absorb trientine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Trientine may cause serious side effects. Call your doctor at once if you have:

• fever or skin rash;

• problems with speech, balance, walking, lifting, chewing, or swallowing;

• muscle pain or stiffness;

• muscle weakness, drooping eyelids, double vision; or

• symptoms of lupus (an autoimmune disorder)--joint pain or swelling, headaches, confusion, chest pain, shortness of breath, skin sores, or numbness, cold feeling, or pale appearance of your fingers or toes.

Common side effects of trientine may include:

• heartburn, stomach pain, loss of appetite;

• black, tarry stools;

• general ill feeling;

• mouth sores; or

• skin flaking, cracking, or thickening.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with trientine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.