Syprine

Trientine is used to treat Wilson's disease, a disease in which there is too much copper in the body.

This medicine combines with excess copper in the body and may prevent your body from absorbing the copper in the foods you eat. Removing copper from the body prevents damage to the liver, brain, and other organs. The combination of copper and trientine is then easily removed by the kidneys and it passes from the body in urine.

Trientine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Capsule

Clinical experience with SYPRINE has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

SYPRINE is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established.

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

Trientine is used to treat Wilson's disease in people who cannot take penicillamine (Cuprimine, Depen).

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

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

Syprine is a prescription medication that is used to treat Wilson's disease.

Syprine belongs to a group of drugs called chelating agents, which help by binding excess heavy metals and increasing the removal of the metals from the body.

Specifically, it can be used to remove the excess copper that is built up in patients with Wilson's disease

This medication comes in capsule form and is typically taken up to four times a day, on an empty stomach (take with plain water only). Take Syprine one hour before a meal or 2 hours after a meal. In addition, take at least 1 hour apart from any other drug, food, or milk.

Swallow capsules whole with water. Do not open or chew capsules.

Common side effects of Syprine include iron deficiency, muscle spasms, muscle contractions, and skin irritation.
 

• Aton Pharma, Inc.

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

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.

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 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.

Trientine hydrochloride is a heavy metal antagonist.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Anemia is especially likely to occur in children during treatment with trientine.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of trientine in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Iron-deficiency—Trientine may make this condition worse

Clinical experience with Syprine has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.

Syprine is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NDC 0187-2120-10

Rx only

Syprine®
(trientine hydrochloride)
Capsules

250 mg

100 Capsules

VALEANT

Summary of Use during Lactation

Limited information indicates that trientine is not detectable in breastmilk. The effect of trientine on breastmilk copper and zinc concentrations in milk is conflicting,[1][2][3] but breastfed infants appear to have normal serum copper and zinc plasma levels. Based on available data, it appears that trientine is acceptable to use during breastfeeding.

Drug Levels

Maternal Levels. Four patients received trientine for Wilson's disease in dosages of 1000, 1500 (2 patients) and 1750 mg daily. Trientine was not detectable by HPLC in the breastmilk of any of the mothers' milk samples.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Three infants were breastfed during maternal treatment of Wilson's disease with trientine. Serum zinc and copper concentrations were normal in these infants.[3]

A center in Turkey reported 23 infants born to mothers with Wilson's disease over a 20-year period. One patient was treated with 600 mg of trientine plus 100 mg of zinc daily. All of the infants were breastfed (extent and duration not specified). One premature infant died at 3 weeks of age (maternal drug not specified), but the other infants had no apparent complications over a median of 51 months (range 13 to 105 months) of follow-up.[4]

Effects on Lactation and Breastmilk

Conflicting data exist on breastmilk concentrations of zinc and copper during therapy of Wilson's disease with trientine. One abstract reported that breastmilk concentrations were normal during therapy,[2] but another abstract from the same authors reported lower milk concentrations of zinc and copper.[1]

Alternate Drugs to Consider

Penicillamine

References

1. Izumi Y. [Can mothers with Wilson's disease give her breast milk to their infant?]. Teikyo Med J. 2012;35:17-24.

2. Kaga F, Kodama H, Shiga K et al. Copper and zinc status in the breast milk of mothers with Wilson disease. J Inherit Metab Dis. 2008;31 (Suppl 1):157. Abstract. DOI: doi:10.1007/s10545-008-9975-0

3. Shiga K, Kaga H, Kodama H et al. Copper and zinc concentrations in the breast milk of mothers with Wilson disease and effects on infants. J Inherit Metab Dis. 2006;29 (Suppl 1):139. Abstract. DOI: doi:10.1007/s10545-006-9995-6

4. Demir K, Soyer OM, Karaca C et al. The course of pregnancy in Wilson's disease-one center, 20 years' experience. Gastroenterology. 2014;146:S-1009. Abstract TU1834.