Topotecan Hydrochloride
(toe-po-tee′can)
Hycamtin
Classifications: ANTINEOPLASTIC; CAMPTOTHECIN; DNA TOPOISOMERASE I INHIBITOR
Therapeutic: ANTINEOPLASTIC
Pregnancy Category: D
AVAILABILITY
Solution for injection; oral capsule
ACTION & THERAPEUTIC EFFECT
Antitumor mechanism is related to inhibition of
the activity of topoisomerase I, an enzyme required for DNA replication.
Topoisomerase I is essential for the relaxation of supercoiled double-stranded
DNA that enables replication and transcription to proceed. Topotecan permits
uncoiling of DNA stands but
prevents recoiling of the two strands
of DNA, resulting in a permanent break
in the DNA strands.
USES
Metastatic ovarian cancer, cervical cancer,
small cell lung cancer.
CONTRAINDICATIONS
Previous hypersensitivity to topotecan,
irinotecan, or other camptothecin analogs; acute infection; severe bone marrow
depression; severe thrombocytopenia; pregnancy (category D), lactation.
CAUTIOUS USE
Myelosuppression; severe renal impairment or
renal failure; history of bleeding disorders; previous cytotoxic or radiation therapy.
ROUTE & DOSAGE
Metastatic Ovarian Cancer and Small Cell Lung
Cancer
Adult: IV 1.5 mg/m2 daily for 5 days starting on day 1 of a 21-day
course. Four courses of therapy recommended. Subsequent doses can be adjusted
by 0.25 mg/m2 depending on toxicity. PO 2.3 mg/m2 × 5 days, repeat q21days
Cervial Cancer
Adult: 0.75 mg/m2
days 1–3 every 3 weeks
Renal Impairment Dosage
Adjustment
CrCl 20–39 mL/min: Use 0.75 mg/m2
Hemodialysis Dosage Adjustment
Supplementation not needed
Toxicity Dosage Adjustment
In severe neutropenia reduce dose by 0.4 mg/m2 for subsequent courses
ADMINISTRATION
Oral
- Capsules must be swallowed whole. They must not
be crushed, chewed, or opened.
- Avoid direct contact of the capsule contents
with the skin or mucous membranes. If contact occurs, wash thoroughly with soap
and water or wash eyes immediately with gently flowing water for at least 15
min.
Intravenous
- Initiate therapy only if baseline neutrophil
count 1500/mm3 or higher and platelet count 100,000/mm3 or higher.
- Do not give subsequent doses until neutrophils 1000/mm3 or higher, platelets
100,000/mm3 or higher, and Hgb greater than 9.0 mg/dL.
- Note: Dosage adjustments to 0.75 mg/m2 are recommended with
moderate renal impairment.
PREPARE: IV Infusion:
Reconstitute each 4-mg vial with 4 mL sterile water
for injection to yield 1 mg/ mL.
- Withdraw the required dose and inject into 50–100 mL of NS or D5W.
- If skin contacts drug during preparation, wash
immediately with soap and water.
ADMINISTER: IV Infusion:
Give over 30 min immediately after preparation.
INCOMPATIBILITIES:
Y-site: Dexamethasone,fluorouracil, mitomycin.
- Store vials at 20°–25° C (68°–77° F); protect
from light. Reconstituted vials are stable for 24 h.
ADVERSE EFFECTS (≥1%)
Body as a Whole: Asthenia, fever, fatigue. GI:
Nausea, vomiting,
diarrhea, constipation, abdominal pain, stomatitis, anorexia, transient elevations in liver function tests. Hematologic: Leukopenia, neutropenia, anemia, thrombocytopenia. Respiratory:
Dyspnea, cough. Skin: Alopecia. CNS:
Headache.
INTERACTIONS
Drug: Increased risk of bleeding with ANTICOAGULANTS, NSAIDs, SALICYLATES, ANTIPLATELET AGENTS. Avoid
use with clozapine, filgrastim, phenytoin, lefunomide,
natalizumab, pimecrolimus, tacrolimus,
tofacitinib, and LIVE VACCINES.
PHARMACOKINETICS
Distribution: 35% bound to plasma proteins. Metabolism: Undergoes pHdependent hydrolysis.
Elimination: ~30% in urine. Half-Life: 2–3 h.
NURSING IMPLICATIONS
Black Box Warning
Topotecan has been
associated with severe bone marrow suppression.
Assessment & Drug Effects
- Assess for GI distress, respiratory distress,
neurosensory symptoms, and S&S of infection throughout therapy.
- Monitor lab tests: Baseline and periodic CBC
with differential; periodic ALT.
Patient & Family Education
- Learn common adverse effects and measures to
control or minimize when possible. Immediately report any distressing adverse
effects to prescriber.
- Avoid pregnancy during therapy.
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