Anemias:

Indications for: DROXIA

To reduce the frequency of painful crises and to reduce the need for blood transfusions in adults with sickle cell anemia with recurrent moderate to severe painful crises.

Adult Dosage:

Swallow whole. Base dose on ideal or actual weight, whichever is less. Initially 15mg/kg/day as a single dose. May increase dose by 5mg/kg/day every 12 weeks to maximum tolerated dose or 35mg/kg/day achieved; do not increase dose if blood counts are between acceptable and toxic range. If blood counts toxic, discontinue until hematologic recovery, see full labeling for dosage adjustments. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg/day; give dose following dialysis (monitor).

Children Dosage:

Not established.

Boxed Warning:

Myelosuppression. Malignancies.

DROXIA Warnings/Precautions:

Risk of severe myelosuppression. Markedly depressed bone marrow function: do not initiate. Monitor CBCs prior to and during therapy; interrupt, reduce dose, or discontinue as needed. Discontinue if confirmed diagnosis of hemolytic anemia. Monitor for secondary malignancies (eg, leukemia, skin cancer). Avoid sun exposure. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Pulmonary toxicity (monitor). Myeloproliferative disorders; discontinue if cutaneous vasculitic ulcerations occur. Obtain fetal hemoglobin (HbF) levels every 3–4 months; may be used to assess efficacy. Renal or hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥1 year (males) after therapy. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

DROXIA Classification:

Antimetabolite.

DROXIA Interactions:

Avoid concomitant didanosine, with or without stavudine, or other antiretrovirals (may cause pancreatitis [monitor], fatal hepatotoxicity, peripheral neuropathy). Avoid live vaccines. Increased risk of vasculitic toxicities with interferon therapy. May cause falsely elevated results in urea, uric acid, and lactic acid assays.

Adverse Reactions:

Leukopenia, thrombocytopenia, anemia, neutropenia, GI upset, anorexia, hair loss, macrocytosis, bleeding, melanonychia; interstitial lung disease.

Note:

Wear disposable gloves when handling caps or bottle.

Metabolism:

Up to 60% of an oral dose undergoes conversion through saturable hepatic metabolism and a minor pathway of degradation by urease found in intestinal bacteria.

Drug Elimination:

Renal (40%).

Generic Drug Availability:

NO

How Supplied:

Caps—60