Cuvrior

Drug overview for CUVRIOR (trientine tetrahydrochloride):

Generic name: trientine tetrahydrochloride (TRYE-en-teen)
Drug class: Wilson's Disease Treatment Agents
Therapeutic class: Antidotes and other Reversal Agents

Trientine is a heavy metal antagonist that selectively chelates copper.

No enhanced Uses information available for this drug.

DRUG IMAGES

CUVRIOR 300 MG TABLET

The following indications for CUVRIOR (trientine tetrahydrochloride) have been approved by the FDA:

Indications:
Wilson's disease

Professional Synonyms:
Hepatolenticular degeneration
Lenticular progressive degeneration
Strumpell-Westphal disease
Westphal's disease
Westphal's pseudosclerosis
Westphal-Strumpell pseudosclerosis
Wilson's syndrome

The following dosing information is available for CUVRIOR (trientine tetrahydrochloride):

Dosing
Administration
Dosing Information
Generic

Recommended dosage regimens of trientine hydrochloride are based on limited clinical experience; studies have not been conducted evaluating specific doses and/or dosing intervals.

Trientine tetrahydrochloride is not substitutable on a mg-per-mg basis with other trientine products.

If switching from a trientine hydrochloride formulation to trientine tetrahydrochloride, note that the content of the active moiety (trientine base) is not the same as trientine tetrahydrochloride. A 250 mg capsuleof trientine hydrochloride contains 167 mg of trientine base; in contrast, each 300 mg tablet of trientine tetrahydrochloride contains 150 mg of trientine base.

Trientine hydrochloride capsules are administered orally on an empty stomach, at least 1 hour before or 2 hours after meals, and at least 1 hour apart from any other oraldrug, food, or milk. The total daily dosage should be administered in divided doses 2-4 times daily. The capsules should be swallowed whole with water and should not be opened or chewed.

Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed immediately with water. Store trientine hydrochloride capsulesin a tightly closed container in the refrigerator at 2-8oC. Trientine tetrahydrochloride tablets are administered on an empty stomach, at least 1 hour before or 2 hours after meals, and at least 1 hour apart from any other oral drug, food, or milk.

The total daily dosage should be administered in divided doses 2 times daily. The tablets should be swallowed whole without crushing, chewing, or dissolving. If a patient has difficulty swallowing a tablet whole, the scored tablet can be divided into 2 equal halves.

Do not remove trientine tetrahydrochloride tablets from blister packs until just before dosing and do not store tablets for future use after the blister has been opened. Store trientine tetrahydrochloride tablets at 20-25degreesC; excursions permitted between 15-30degreesC.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for CUVRIOR (trientine tetrahydrochloride):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 0 severe interactions.

There are 2 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Trientine/Iron Salts, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Trientine is a chelating agent. Concurrent administration with iron may reduce the absorption of both trientine and iron. CLINICAL EFFECTS: Iron may decrease the levels and clinical effects of trientine, and trientine may reduce serum iron levels. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid use of iron salts within 2 hours of trientine dose. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary. DISCUSSION: Multivitamins with low doses of iron may decrease trientine absorption so ensure patient is aware of the risks. Also, as patients may be unaware which foods contain iron, instruct patients to take trientine on an empty stomach, at least one hour before meals or two hours after food or milk.	ACCRUFER, AUROVELA 24 FE, AUROVELA FE, AURYXIA, BALCOLTRA, BLISOVI 24 FE, BLISOVI FE, CHARLOTTE 24 FE, FEIRZA, FERRIC CITRATE, FINZALA, GEMMILY, HAILEY 24 FE, HAILEY FE, JOYEAUX, JUNEL FE, JUNEL FE 24, KAITLIB FE, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEVONORG-ETH ESTRAD-FE BISGLYC, LO LOESTRIN FE, LOESTRIN FE, MERZEE, MIBELAS 24 FE, MICROGESTIN FE, MINZOYA, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRONE-E.ESTRADIOL-IRON, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-LEGEST FE, VELPHORO, WYMZYA FE, XARAH FE, XELRIA FE
Trientine/Selected Minerals, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Mineral supplements may bind to trientine and block its absorption. CLINICAL EFFECTS: The levels and clinical effects of trientine may be decreased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of trientine states that mineral supplements should not be given with trientine. If concomitant therapy is necessary, take trientine on an empty stomach and separate administration at least one hour apart from any other drug. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary. DISCUSSION: Multivitamins with minerals may decrease trientine absorption so ensure patient is aware of the risks.	AVIDOXY DK, CALCIUM ACETATE, CALCIUM CHLORIDE, CALCIUM GLUCONATE, CALCIUM GLUCONATE MONOHYDRATE, GALZIN, LUGOL'S, MAGNESIUM CITRATE, POTASSIUM IODIDE, SOD SULF-POTASS SULF-MAG SULF, SSKI, STRONG IODINE, SUFLAVE, SUPREP, SUTAB, WILZIN, ZINC ACETATE, ZINC CHLORIDE, ZINC OXIDE, ZINC SULFATE

Drug Interaction

Drug Names

Trientine/Iron Salts, Oral

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Trientine is a chelating agent. Concurrent administration with iron may reduce the absorption of both trientine and iron.

CLINICAL EFFECTS: Iron may decrease the levels and clinical effects of trientine, and trientine may reduce serum iron levels.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Avoid use of iron salts within 2 hours of trientine dose. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary.

DISCUSSION: Multivitamins with low doses of iron may decrease trientine absorption so ensure patient is aware of the risks. Also, as patients may be unaware which foods contain iron, instruct patients to take trientine on an empty stomach, at least one hour before meals or two hours after food or milk.

ACCRUFER, AUROVELA 24 FE, AUROVELA FE, AURYXIA, BALCOLTRA, BLISOVI 24 FE, BLISOVI FE, CHARLOTTE 24 FE, FEIRZA, FERRIC CITRATE, FINZALA, GEMMILY, HAILEY 24 FE, HAILEY FE, JOYEAUX, JUNEL FE, JUNEL FE 24, KAITLIB FE, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEVONORG-ETH ESTRAD-FE BISGLYC, LO LOESTRIN FE, LOESTRIN FE, MERZEE, MIBELAS 24 FE, MICROGESTIN FE, MINZOYA, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRONE-E.ESTRADIOL-IRON, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-LEGEST FE, VELPHORO, WYMZYA FE, XARAH FE, XELRIA FE

Trientine/Selected Minerals, Oral

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Mineral supplements may bind to trientine and block its absorption.

CLINICAL EFFECTS: The levels and clinical effects of trientine may be decreased.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of trientine states that mineral supplements should not be given with trientine. If concomitant therapy is necessary, take trientine on an empty stomach and separate administration at least one hour apart from any other drug. Monitor clinical status for decreased effectiveness and adjust the trientine dose if necessary.

DISCUSSION: Multivitamins with minerals may decrease trientine absorption so ensure patient is aware of the risks.

AVIDOXY DK, CALCIUM ACETATE, CALCIUM CHLORIDE, CALCIUM GLUCONATE, CALCIUM GLUCONATE MONOHYDRATE, GALZIN, LUGOL'S, MAGNESIUM CITRATE, POTASSIUM IODIDE, SOD SULF-POTASS SULF-MAG SULF, SSKI, STRONG IODINE, SUFLAVE, SUPREP, SUTAB, WILZIN, ZINC ACETATE, ZINC CHLORIDE, ZINC OXIDE, ZINC SULFATE

Moderate List
Iron deficiency anemia

The following adverse reaction information is available for CUVRIOR (trientine tetrahydrochloride):

Overview
Severe
Less Severe

Adverse reaction overview.

Data on adverse effects associated with trientine hydrochloridetherapy are limited; iron deficiency and systemic lupus erythematosus were reported in a clinical study of trientine in patients with Wilson disease. The most common adverse effects (>5%) with trientine tetrahydrochloride are abdominal pain, change of bowel habits, rash, alopecia, and mood swings.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
Anemia	Systemic lupus erythematosus

Rare/Very Rare
Acquired dystonia Allergic dermatitis Skin rash Urticaria

There are 6 less severe adverse reactions.

More Frequent	Less Frequent
Nausea	None.

Rare/Very Rare
Dysarthria Muscle spasm Muscle weakness Pruritus of skin Tremor

The following precautions are available for CUVRIOR (trientine tetrahydrochloride):

Pediatric
Pregnant
Lactation
Geriatric

Although no controlled studies have been conducted specifically in pediatric patients, trientine hydrochloridehas been used clinically in patients as young as 6 years of age with no reported adverse experiences.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Because interruption of therapy for Wilson disease during pregnancy has resulted in acute liver failure, the American Association for the Study of Liver Diseases (AASLD) states that treatment should be continued during pregnancy. Although clinical experience is limited, use of trientine during pregnancy has been associated with successful outcomes for both mother and fetus. TheAASLD recommends that thedosage of trientine hydrochloride be reduced to the minimum necessary dosage during pregnancy, particularly during the third trimester, to promote better wound healing if cesarean section is performed. A dosage reduction of 25-50% of the pre-pregnancy dosage has been recommended with frequent monitoring of the patient.

The AASLD suggests that all medications used to treat Wilson disease are excreted into breast milk and generallyrecommends against use of these agents in nursing women due to the risk of causing copper deficiency in the infant.

The manufacturer makes no specific dosage recommendations for geriatric patients. Use caution and initiate treatmentat the lower end of the dosing range in geriatric patients. Clinical studies of trientine did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Use trientine withcaution and initiate treatment at the lower end of the dosing range in geriatric patients.