Datopotamab Deruxtecan-dlnk

Datopotamab Deruxtecan is a Trop-2 directed antibody indicated for unresectable or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2  (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in adults who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

• Datopotamab Deruxtecan is available under the following different brand names: Datopotamab Deruxtecan-dlnk, Datroway.

Common side effects of Datopotamab Deruxtecan include:

• nausea
• tiredness
• decreased white blood cell counts
• decreased calcium
• hair loss
• decreased red blood cell counts
• constipation
• dry eye
• vomiting
• increased blood levels of liver enzymes
• an eye problem called keratitis

Serious side effects of Datopotamab Deruxtecan include:

• lung problem symptoms such as cough, trouble breathing or shortness of breath, fever, and other new or worsening breathing symptoms such as chest tightness or wheezing 
• eye problem symptoms such as dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from the eyes, eye crusting, sensitivity to light, blurred vision, or vision changes
• mouth ulcers and sores symptoms such as mouth pain, swelling, redness, ulcers, or sores

Rare side effects of Datopotamab Deruxtecan include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder

• 100 mg single-dose vial

Breast cancer

Adult dosage

• Premedicate with diphenhydramine IV/Oral, acetaminophen IV/Oral, and antiemetics (e.g., 5-HT3 serotonin receptor antagonist) IV/Oral with or without systemic corticosteroids before each infusion
• 6 mg/kg (maximum dose, 540 mg) IV every 3 weeks until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Datopotamab Deruxtecan has no noted severe interactions with any other drugs
• Datopotamab Deruxtecan has no noted serious interactions with any other drugs
• Datopotamab Deruxtecan has no noted moderate interactions with any other drugs
• Datopotamab Deruxtecan has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Datopotamab Deruxtecan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Datopotamab Deruxtecan?”

Cautions

• Interstitial lung disease (ILD) and pneumonitis 
  • Datopotamab Deruxtecan can cause severe and fatal cases of ILD/pneumonitis 
  • For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (e.g., 0.5 mg/kg/day and more prednisolone or equivalent)
  • For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., 1 mg/kg/day and more prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.
  • Withhold Datopotamab Deruxtecan in patients with suspected ILD/pneumonitis and permanently discontinue Datopotamab Deruxtecan if Grade 2 and higher ILD/pneumonitis is confirmed
• Ocular adverse reactions
  • Datopotamab Deruxtecan can cause ocular adverse reactions including dry eye, keratitis, blepharitis and meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision
  • Monitor patients for ocular adverse reactions during treatment with Datopotamab Deruxtecan 
  • Advise patients to use preservative-free lubricating eye drops and to avoid using contact lenses during treatment with Datopotamab Deruxtecan
  • Dose delay, dose reduction, or permanently discontinue Datopotamab Deruxtecan based on the severity of ocular adverse reactions
  • Refer patients to an eye care professional for any new or worsening ocular signs and symptoms
• Stomatitis/oral mucositis 
  • Datopotamab Deruxtecan can cause stomatitis, including mouth ulcers and oral mucositis. 
  • Advise patients to use a steroid-containing mouthwash when starting treatment and to hold ice chips or ice water in the mouth during the infusion of Datopotamab Deruxtecan 
  • Based on the severity of the adverse reaction, withhold dose reduce, or permanently discontinue Datopotamab Deruxtecan 
• Embryo-fetal toxicity 
  • Datopotamab Deruxtecan can cause fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of Datopotamab Deruxtecan, is genotoxic and affects actively dividing cells
  • Advise patients of potential risks to a fetus and to use effective contraception
  • Advise female patients of reproductive potential to use effective contraception during treatment with Datopotamab Deruxtecan and for 7 months after the last dose
  • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Datopotamab Deruxtecan and for 4 months after the last dose

Pregnancy and Lactation

Based on its mechanism of action, Datopotamab Deruxtecan can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of Datopotamab Deruxtecan, DXd, is genotoxic and affects actively dividing cells. 

There are no available data on the use of Datopotamab Deruxtecan in pregnant women to inform a drug-associated risk. 

Advise patients of the potential risks to a fetus.

Females and males of reproductive potential

Datopotamab Deruxtecan can cause embryo-fetal harm when administered to a pregnant woman 

Pregnancy testing

• Verify the pregnancy status of females of reproductive potential before initiation of Datopotamab Deruxtecan 

Contraception

• Females
  • Advise females of reproductive potential to use effective contraception during treatment with Datopotamab Deruxtecan and for 7 months after the last dose
• Males
  • Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with Datopotamab Deruxtecan and for 4 months after the last dose 

Infertility

• Based on findings in animal toxicity studies, Datopotamab Deruxtecan may impair male and female reproductive function and fertility
• The effects on reproductive organs in animals were irreversible

Lactation

• There are no data regarding the presence of Datopotamab Deruxtecan-dlnk or its metabolites in human milk, its effects on the breastfed child, or milk production
• Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Datopotamab Deruxtecan and for 1 month after the last dose