Gavreto (Pralsetinib)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Gavreto (pralsetinib) is a prescription medication used to treat:
- Adults with RET positive (RET+) non-small cell lung cancer that has spread
- Adults and children who are at least 12 years old with RET+ advanced thyroid cancer or thyroid cancer that has spread who require an oral or injectable medication and who have not responded well to prior radioactive iodine treatment
Gavreto is available in 100 mg oral capsules.
Fact Table
Formula
C27H32FN7O3
License
US FDA
Bioavailability
~73%
Legal status
Prescription only (Rx)
Chemical Name
Pralsetinib
Elimination half-life
~14.7 hours
Dosage (Strength)
100 mg and 200 mg capsules; usual adult dose: 400 mg orally once daily
Pregnancy
Contraindicated (can cause fetal harm)
Brands
Gavreto
Protein binding
97.1%
PubChem CID
121494679
MedlinePlus
a621015
ChEBI
182209
ATC code
L01EX21
DrugBank
DB15684
KEGG
D12194
Routes of administration
Oral
Directions
Take Gavreto exactly as prescribed by your doctor. Gavreto should be taken on an empty stomach. For further instructions for use, you may refer to the information leaflet that comes with your prescription. If you have any questions or concerns, talk to your healthcare provider or pharmacist.
Gavreto should be stored at room temperature between 68°F to 77°F (20°C to 25°C) and away from moisture.
Ingredients
The active ingredient in Gavreto 100 mg capsules is pralsetinib. Inactive ingredients include citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch, sodium bicarbonate, FD&C Blue #1 (Brilliant Blue FCF), hypromellose, titanium dioxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, and titanium dioxide.
Contraindications
According to the most recent Prescribing Information, there are no contraindications, or reasons why a person should not receive Gavreto. However, patients should talk to their healthcare provider about whether Gavreto is an appropriate treatment option for them.
Cautions
- Before you begin taking Gavreto, talk to your healthcare provider about:
- All the medications you take, including prescription and over-the-counter medications
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Gavreto contains the following warnings and precautions:
- Lung inflammation that may be severe or life-threatening. Notify your healthcare provider right away if you have shortness of breath, cough, or fever.
- High blood pressure that can be severe. It is recommended to regularly monitor your blood pressure during treatment with Gavreto. Notify your healthcare provider right away if you have confusion, dizziness, headaches, chest pain, or shortness of breath.
- Liver problems that can be serious. Notify your healthcare provider right away if you have yellowing of your skin or whites of your eyes, appetite loss, nausea, vomiting, dark urine, pain on the upper right side of your stomach, sleepiness, bleeding, or bruising.
- Bleeding disorders that can be serious. Notify your healthcare provider right away if you are vomiting blood or if your vomit looks like coffee grounds, you are coughing up blood, or if you have headaches, abnormal bleeding or bruising, change in speech, confusion, pink or brown urine, red or black stools, drowsiness, frequent nose bleeds, or your menstrual period is heavier than usual.
- Tumor lysis syndrome. Notify your healthcare provider right away if you have nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures, or swelling.
- Problems with wound healing. Notify your healthcare provider of any planned surgeries. Do not take Gavreto for at least 5 days before surgery. Your doctor will tell you when you can resume taking Gavreto.
Side Effects
Musculoskeletal pain, constipation, diarrhea, fatigue, swelling, fever, and cough are common Gavreto side effects. However, other side effects may also occur. Tell your healthcare provider right away if you have side effects that bother you or won’t go away.
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Reference
Gavreto. South San Francisco, CA: Genentech, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14448
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