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 clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [ see Warnings and Precautions ( 5.1 ) ] Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC at 1-888-724-3274 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 pooled safety population described in the Warnings and Precautions reflects exposure to ROMVIMZA in 83 patients with TGCT enrolled in the double-blind portion and in 35 patients with TGCT in the open-label portion who crossed over to ROMVIMZA in MOTION, and in 135 patients with TGCT or solid tumors in other clinical trials.
The safety of ROMVIMZA was evaluated in 83 adult patients with TGCT in MOTION [ see Clinical Studies ( 14 ) ].
MOTION excluded patients with bilirubin, AST, or ALT >ULN.
All patients received ROMVIMZA twice weekly until disease progression or unacceptable toxicity.
Among these patients, 82% were exposed for 6 months or longer and 30% were exposed for greater than one year.
Serious adverse reactions occurred in 2.4% of patients who received ROMVIMZA.
Serious adverse reactions in ≥1% included subcutaneous abscess (1.2%) and cellulitis (1.2%).
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Elevated AST and ALT can occur.
Evaluate liver tests prior to initiation of treatment and during treatment.
( 2.2 , 5.1 ) Embryo-fetal toxicity: Can cause fetal harm.
Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.
( 5.2 , 8.1 , 8.3 ) Allergic Reactions to FD&C Yellow No.
Like all medications, Romvimza 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: