TIVDAK 40 mg/4mL
tisotumab vedotin · INJECTION, POWDER, FOR SOLUTION · SEAGEN INC.
TIVDAK is a injection, powder, for solution containing tisotumab vedotin at 40 mg/4mL, taken intravenous. Manufactured by SEAGEN INC..
Key Facts
- Brand Name
- TIVDAK
- Generic Name
- tisotumab vedotin
- NDC Code (Product)
51144-003- Manufacturer
- SEAGEN INC.
- Strength
- 40 mg/4mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761208
- Marketing Start
- 09/20/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For intravenous infusion only. Do not administer TIVDAK as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products. ( 2.4 ) • The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. 2.2 Premedication and Required Eye Care Adhere to the following recommendations to reduce the risk of ocular adverse reactions [see Warnings and Precautions (5.1) ]. • Ophthalmic exam by eye care provider: Conduct an ophthalmic exam prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. The ophthalmic exam should include visual acuity, slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement. • Topical corticosteroid eye drops: Instruct patients to administer one drop in …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Closely monitor for TIVDAK adverse reactions. ( 7.1 ) 7.1 Effects of Other Drugs on TIVDAK Strong CYP3A4 Inhibitors MMAE is a CYP3A4 substrate. Concomitant use of TIVDAK with strong CYP3A4 inhibitors may increase unconjugated MMAE exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for adverse reactions of TIVDAK when used concomitantly with strong CYP3A4 inhibitors.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Ocular Adverse Reactions [see Boxed Warning , Warnings and Precautions (5.1) ] • Peripheral Neuropathy [see Warnings and Precautions (5.2) ] • Hemorrhage [see Warnings and Precautions (5.3) ] • Pneumonitis [see Warnings and Precautions (5.4) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine aminotransferase increased, and hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-4SEAGEN or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the WARNINGS AND PRECAUTIONS section reflect exp…
Frequently Asked Questions
What is TIVDAK used for?
TIVDAK contains tisotumab vedotin. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is TIVDAK a controlled substance?
TIVDAK is not classified as a controlled substance by the DEA.
What is the generic name for TIVDAK?
The generic name for TIVDAK is tisotumab vedotin. There are no other listed brand versions of tisotumab vedotin.
What is the NDC code for TIVDAK 40 mg/4mL?
The NDC (National Drug Code) for TIVDAK 40 mg/4mL is 51144-003, listed by SEAGEN INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)