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.
Xalkori (Crizotinib)
Prescription Required
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Product Details
Description
Xalkori (crizotinib) is a prescription medication used to treat non-small cell lung cancer (NSCLC) in adults; relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) in young adults and pediatric patients who at least 1 years old; and unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) in adults and pediatric patients who are least 1 years old.
Xalkori is available in 200 mg and 250 mg oral capsules. It is also available in 20 mg, 50 mg, and 150 mg oral pellets.
Fact Table
Formula
C21H22Cl2FN5O
License
US FDA, EMA
Bioavailability
43%
Legal status
Prescription only (Rx)
Chemical Name
3-[(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-(1-piperidinyl)-pyrazine-2(1H)-4-pyridineamine
Elimination half-life
42 hours
Dosage (Strength)
Capsules: 200 mg, 250 mg
Pregnancy
Contraindicated
Brands
Xalkori
Protein binding
91%
PubChem CID
11626560
MedlinePlus
a611011
ChEBI
CHEBI:516230
ATC code
L01XE16
DrugBank
DB08865
KEGG
D09712
Routes of administration
Oral
Directions
Take Xalkori exactly as prescribed by your or your child’s doctor, who will determine an appropriate dose and treatment regimen based on weight and the condition being treated.
Store Xalkori capsules and oral pellets between 20°C and 25°C (68°F and 77°F) and out of children’s reach.
For further instructions for use, refer to the medication guide that comes with the Xalkori prescription.
If you have any questions or concerns, talk to the doctor or pharmacist.
Ingredients
The active ingredient in Xalkori is crizotinib.
Inactive ingredients in the capsules include colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, and hard gelatin capsule shells. Gelatin, titanium dioxide, and red iron oxide are also included in the pink opaque capsule shell. Gelatin and titanium dioxide are also included in the white opaque capsule shell. Shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide make up the printing ink.
Inactive ingredients in the uncoated oral pellets include poloxamer and stearyl alcohol. The film-coating includes hypromellose, glyceryl monostearate, medium chain triglycerides, polyethylene glycol/macrogol, sucrose, and talc.
Contraindications
According to the most recent Prescribing Information, there are no contraindications to taking Xalkori.
Cautions
- Before you or your child starts treatment with Xalkori, tell the doctor about:
- All the prescription and over-the-counter medications you or your child takes
- Your or your child’s allergies
- Your or your child’s current health problems and past medical history
- Your or your child’s pregnancy or breastfeeding status
- Xalkori is associated with the following warnings and precautions:
- Liver problems
- Interstitial lung disease/pneumonitis
- QT interval prolongation, a type of abnormal heart rhythm
- Slow heart rate
- Severe vision loss
- Stomach and intestinal toxicity, resulting in severe nausea, vomiting, diarrhea, and inflamed/sore mouth
- Harm to an unborn baby; females capable of reproduction should use effective contraceptive methods during Xalkori treatment and for 45 days after taking the final dose. Additionally, males with female partners who are capable of reproduction should use condoms during treatment with Xakori and for 90 days after taking the final dose
- Breastfeeding is not recommended
Side Effects
The most common Xalkori side effects in patients being treated for:
- NSCLC: vision problems, nausea, diarrhea, vomiting, swelling, constipation, increased liver enzymes, fatigue, appetite loss, upper respiratory infection, dizziness, and neuropathy
- ALCL: diarrhea, vomiting, nausea, vision problems, headache, musculoskeletal pain, inflamed/sore mouth, fatigue, appetite loss, fever, abdominal pain, cough, itching, laboratory abnormalities (decreased neutrophils, lymphocytes, and platelets)
- Adults with IMT: vision problems, nausea, and edema
- Pediatric patients with IMT: vomiting, nausea, diarrhea, abdominal pain, rash, vision problems, upper respiratory tract infection, cough, fever, musculoskeletal pain, fatigue, swelling, constipation, and headache
Immediately contact your or your child’s doctor about any side effects that bother you or your child or side effects that won’t go away.
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Reference
Xalkori. New York, NY: Pfizer, 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 : 14630
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