DEPEN (penicillamine)

There are 4 contraindications. Absolute contraindication.

Contraindication List
Agranulocytosis
Aplastic anemia
Aplastic anemia secondary to drugs
Kidney disease with reduction in glomerular filtration rate (GFr)

There are 10 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bronchiolitis
Glomerulonephritis
Hematuria
Leukopenia
Lupus-like syndrome
Myasthenia gravis
Pemphigus
Pregnancy
Proteinuria
Thrombocytopenic disorder

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Aphthous stomatitis
Iron deficiency anemia

There are 26 severe adverse reactions.

More Frequent	Less Frequent
Allergic dermatitis Aphthous stomatitis Pruritus of skin Skin rash Stomatitis Urticaria	Agranulocytosis Aplastic anemia Glomerulonephritis Hemolytic anemia Leukopenia Thrombocytopenic disorder

Rare/Very Rare
Acute pancreatitis Angioedema Bronchiolitis obliterans Eosinophilia Exacerbation of peptic ulcer Exfoliative dermatitis Goodpasture's syndrome Jaundice Lupus-like syndrome Myasthenia gravis Optic neuritis Pemphigus Tinnitus Toxic epidermal necrolysis

There are 10 less severe adverse reactions.

More Frequent	Less Frequent
Abdominal pain with cramps Anorexia Diarrhea Dysgeusia Nausea Vomiting	None.

Rare/Very Rare
Hematuria Maculopapular rash Proteinuria Urinary incontinence

One cystinuric patient treated with penicillamine throughout pregnancy delivered a child with a generalized connective tissue defect which may have been caused by penicillamine. The manufacturers state that, if possible, the drug should not be administered during pregnancy to women with cystinuria. If stones continue to form in cystinuric women, the potential benefits of penicillamine therapy must be weighed against the possible risks.

One woman with rheumatoid arthritis treated with less than 900 mg of penicillamine daily during pregnancy delivered (by cesarean section) an infant with growth retardation, flattened face with broad nasal bridge, low-set ears, short neck with loose skin folds, and unusually lax body skin. The manufacturers state that penicillamine is contraindicated in women with rheumatoid arthritis who are pregnant. The drug should not be used in women with rheumatoid arthritis who may become pregnant unless the possible benefits outweigh the risks; if pregnancy is suspected or occurs in these women during penicillamine therapy, the drug should be discontinued.

Women with rheumatoid arthritis receiving penicillamine should be informed about the possible hazards of the drug to the fetus and should be advised to promptly report to their physician any missed menstrual periods or other indication of possible pregnancy. To date, there have been no reports of serious adverse fetal effects when penicillamine was used for the treatment of Wilson disease in pregnant women. One woman with Wilson disease who received 1.5

g of penicillamine daily during pregnancy delivered an infant with loose body skin; at 9 weeks of age the infant's skin was normal. It appears that continued penicillamine therapy in these patients prevents relapse of Wilson disease and that discontinuance of the drug may be deleterious to the mother; however, dosage should be limited to 750 mg daily. In patients with Wilson disease in whom a cesarean section is planned, dosage of penicillamine should be limited to 250 mg daily during the 6 weeks before delivery and postoperatively until wound healing is complete in order to preclude impairment of wound healing.

Although there are no studies to date using penicillamine in nursing women, the manufacturers state that nursing should not be undertaken by women receiving the drug.

No enhanced Geriatric Use information available for this drug.