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Datopotamab deruxtecan

Class
Targeted therapy
Subclass
Anti-TROP2 monoclonal antibody and topoisomerase inhibitor conjugate
Generic name
Datopotamab deruxtecan, datopotamab deruxtecan-dlnk
Brand names
Datroway®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of breast cancer • Unresectable or metastatic, HR-positive, HER2-negative, following endocrine-based therapy and chemotherapy
•
6 mg/kg IV q3 weeks (21-day cycle), administered as an intravenous infusion, until disease progression or unacceptable toxicity
Indications for use
Labeled indications
Adults
•
Treatment of breast cancer (unresectable or metastatic, HR-positive, HER2-negative, following endocrine-based therapy and chemotherapy)
Safety risks
Warnings and precautions
ILD
•
Maintain a high level of suspicion, as datopotamab deruxtecan has been associated with an increased risk of severe, life-threatening, or fatal ILD/pneumonitis. Consider administering corticosteroids for asymptomatic (grade 1) ILD/pneumonitis. Administer systemic corticosteroids promptly for symptomatic ILD/pneumonitis (grade ≥ 2) and continue for at least 14 days, followed by a gradual taper over at least 4 weeks. Withhold datopotamab deruxtecan in patients with suspected ILD/pneumonitis and resume at the same dose if resolved within 28 days. or at a reduced dose (4 mg/kg for the first reduction, up to a maximum of 360 mg for patients ≥ 90 kg; 3 mg/kg for the second reduction, up to a maximum of 270 mg for patients ≥ 90 kg) if resolved after 28 days. Permanently discontinue datopotamab deruxtecan if grade > 2 ILD/pneumonitis is confirmed.
Ocular adverse reactions
•
Maintain a high level of suspicion, as datopotamab deruxtecan has been associated with an increased risk of ocular adverse reactions, including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis and to avoid contact lens use. Delay, reduce the dose, or permanently discontinue datopotamab deruxtecan based on the severity of adverse reactions.
Stomatitis
•
Maintain a high level of suspicion, as datopotamab deruxtecan can cause stomatitis, including oral ulcers and mucositis. Advise patients to use a corticosteroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct patients to hold ice chips or ice water in the mouth throughout the infusion of datopotamab deruxtecan. Increase the frequency of mouthwash and administer other topical treatments as clinically indicated if stomatitis occurs. Withhold, reduce the dose (4 mg/kg for the first reduction, up to a maximum of 360 mg for patients ≥ 90 kg; 3 mg/kg for the second reduction, up to a maximum of 270 mg for patients ≥ 90 kg), or permanently discontinue datopotamab deruxtecan based on the severity of stomatitis.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required. Monitor respiratory function. Monitor for adverse reactions.
CrCl < 30 mL/min
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use with caution. Monitor for adverse reactions.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Avoid use. Datopotamab deruxtecan can cause embryo-fetal harm when administered to a pregnant woman based on the mechanism of action of deruxtecan. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.
Breastfeeding
Halt breastfeeding temporarily.
•
Advise females not to breastfeed for 1 month after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, ↓ WBC count, ↓ blood lymphocyte count, ↓ blood neutrophil count, ↓ serum calcium, ↑ serum AST, ↑ serum ALP, keratitis, ↑ serum ALT, vomiting, blurred vision, constipation, cough, diarrhea, abdominal pain, dry eyes, fatigue, hair loss, loss of appetite, nausea, skin rash, stomatitis
Common 1-10%
•
Blepharitis, tearing, interstitial lung disease, pneumonitis, meibomian gland dysfunction
Interactions
Drug(s)
Check Interactions
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