Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 exposure to TIVDAK in 425 patients with recurrent or metastatic cervical cancer who received at least one dose of TIVDAK at 2 mg/kg intravenously every 3 weeks in innovaTV 301, innovaTV 204, innovaTV 201 (NCT02001623), innovaTV 202 (NCT02552121), innovaTV 203 (NCT03245736), and innovaTV 206 (NCT03913741).
The median duration of treatment with TIVDAK was 3.7 months (range: 0.4-40.2).
In this pooled safety population, the most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (45%), peripheral neuropathy (39%), conjunctival adverse reactions (38%), nausea (37%), fatigue (36%), aspartate aminotransferase increased (33%), epistaxis (33%), alopecia (31%), alanine aminotransferase increased (30%), and hemorrhage (28%).
The data described in this section reflect exposure to TIVDAK from innovaTV 301 and innovaTV
innovaTV 301 The safety of TIVDAK was evaluated in an open-label, randomized study in patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy [see Clinical Studies (14.1) ].
A total of 250 patients received TIVDAK 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
5 WARNINGS AND PRECAUTIONS • Peripheral neuropathy: Monitor patients for new or worsening peripheral neuropathy.
Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity.
( 2.3 , 5.2 ) • Hemorrhage: Monitor patients for signs and symptoms of hemorrhage.
Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity.
( 2.3 , 5.3 ) • Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur.
Like all medications, Tivdak can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: