Trientine

Trientine is used to treat Wilson's disease, which is a rare inherited condition that leads to high copper levels in the body.

Your doctor will decide which brand of trientine is the best treatment for you.

Trientine is used when other treatments are not effective or did not work.

Trientine may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label, or as prescribed by your doctor.

Trientine is usually taken twice and up to four times per day. You may need to take several capsules or tablets to receive your full dose. Follow your doctor's instructions.

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

Swallow the capsule whole with a full glass of water and do not crush, chew, break, or open it.

Swallow the tablet whole and do not crush, chew, or dissolve it. If you cannot swallow a tablet whole, you may split it in half and take it right away. Do not store any tablet for later use after removing it from the package. Ask your pharmacist if you have any questions.

Your blood will need to be tested before and during treatment with trientine, and you may need other medical tests. Your doctor will need to check your progress on a regular basis.

You may be given other medications to help treat certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

Call your doctor if your symptoms do not improve, or if you have a fever or rash. You may need to take your temperature every night for the first month of treatment with trientine.

Store the capsules tightly closed in their original container. Some trientine capsule brand forms are stored in the refrigerator. Others are stored at room temperature. Ask your pharmacist how to properly store trientine capsules.

Store the tablets at room temperature, away from moisture and heat. Keep the tablets in the blister pack until you are ready to take the medicine.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use trientine if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• rheumatoid arthritis;
• high levels of cystine (an amino acid) in urine;
• a mineral deficiency (iron, zinc, magnesium, or others);
• trouble swallowing;
• a neurologic disorder or disease; or
• liver disease (especially if you have biliary cirrhosis).

It is not known if trientine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Having Wilson's disease during pregnancy can cause complications or medical problems in both the mother and the baby. The benefit of treating Wilson's disease may outweigh any risks to the baby.

Ask a doctor if it is safe to breastfeed while using trientine.

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

Trientine may cause serious side effects. Call your doctor right away if you have:

• fever or skin rash, no matter how mild;
• signs of copper deficiency—weakness, confusion, loss of balance or coordination, numbness, tingling, weight loss;
• low red blood cells (anemia)—pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or
• lupus-like symptoms—muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Your treatment may be permanently stopped if you have certain side effects.

Common side effects of trientine may include:

• stomach pain, changes in bowel habits;
• mood changes; or
• rash, hair loss.

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.

Usual Adult Dose for Wilson's Disease:

750 to 1250 mg, orally, in divided doses given 2, 3, or 4 times dailyMaximum dose: 2000 mg dailyComments:-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 dailyMaximum dose: 2000 mg daily12 and under:500 to 750 mg, orally, in divided doses given 2, 3, or 4 times dailyMaximum dose: 1500 mg dailyComments:-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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

Ask your doctor before taking a mineral supplement (iron, zinc, magnesium, and others), and take only the type your doctor recommends.

If this medication gets on your skin, wash the area with soap and water.

Take your trientine dose 2 hours before or 2 hours after taking any iron supplement or medication.

You also need to take your trientine dose at least 1 hour before or 2 hours after taking other mineral supplements (zinc, magnesium, calcium, and others).

Do not take any other medication by mouth within 1 hour before or after you take trientine.

Other drugs may affect trientine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.