New Drug: FDA Approved Ayvakit (avapritinib) Drug 2020

New Drug : Ayvakit

Ayvakit

(avapritinib)

• FDA Approved: Yes (First approved on 9 January 2020)
• Name of Brand: Ayvakit
• Common name: avapritinib
• Type of dosage: Tablets
• Manufacturer : Blueprint Medicines Corporation
• Treatment for: Stromal gastrointestinal tumor. 

Ayvakit:

The kinase inhibitor Ayvakit is the exon-18 mutant gastrointestinal current (GIST) tumor promoter for the treatment of PDGFRα (Platelet-Derived Growth Factor Receptor Alpha ) exones. 

• Ayvakit is a tablet that is taken from an empty stomach once a day.
• Ayvakit can cause serious side effects, including bleeding inside the brain, effects on the central nervous system, and injury to a newborn infant. Rare side effects include swelling, nausea , fatigue, difficulty breathing, vomiting, reduced appetite, diarrhea, changes in hair colour, increased tear secretion, stomach pain , constipation, rash and dizziness. 
• Ayvakit is a prescribed drug used to treat adults with a specific form of cancer of the liver, intestine, or esophagus called gastrointestinal stromal tumor (GIST) that can not be handled through chemotherapy or has spread to certain areas of the body (metastatic) owing to certain defective platelet-derived growth factor alpha (PDGFRA) genes. The health care professional will administer a screening to ensure that you have this rare PDGFRA gene and whether Ayvakit is correct for you. If Ayvakit is safe and effective in children remains unclear.

Instruction Before taking Ayvakit:

Tell your healthcare provider about all of your medical conditions before you start treatment, including if you Are pregnant or plan to get pregnant. Ayvakit will hurt the unborn child.

• Females in a position to become pregnant:
• Before you begin treatment, your healthcare provider should do a pregnancy test.
• Active birth control (contraception) will be used during therapy and for 6 weeks after final dosage. Talk to your healthcare provider about methods of birth control which may be right for you.
• If you become pregnant or think you may be pregnant during the treatment, tell your healthcare provider immediately.
• Males with pregnant female partners will use adequate birth control (contraception) during care, including 6 weeks following the final dosage.
• Are breastfeeding or breastfeeding planned. It is not clear if Ayvakit gets into your breast milk. Should not breastfeed during the procedure, except after the final dosage for at least 2 weeks. Discuss with your health care provider the best way to feed your baby during this time.
• Asking the health care professional of all the medications you are taking, including over-the-counter and prescribed drugs, minerals, and herbal supplements. Ayvakit may influence how other drugs function, and may change the way Ayvakit operates. Converse with the healthcare professional before beginning a new drug.

How To Take AYVAKIT:

• Take Ayvakit just as you're instructed by your health care professional to handle it.
• Do not adjust dosage or avoid taking Ayvakit until you are instructed to do so by your health care professional.
• If you develop side effects, your healthcare provider may change your dose, stop temporarily or stop treatment with Ayvakit permanently.
• Take Ayvakit 1x daily.
• Taking an empty stomach Ayvakit tablet(s) at least 1 hour before, and at least 2 hours after dinner.
• When you skip an Ayvakit injection, take it as soon as you recall, until the next injection is expected within 8 hours. Take the next dose at regular intervals.
• If you vomit after taking an Ayvakit dose do not take an additional dose. Perform the next dose at the next planned time.

Avoid This When Taking Ayvakit:

Should not drive or run heavy equipment while you're having doubt or difficulty thinking with Ayvakit during treatment.

Side Effects:

It may cause serious side effects including:

• Your brain bleeds. Avoid taking Ayvakit and inform your health care provider if you experience any symptoms on one side of your body, such as extreme headache, vision issues, extreme sleepiness, severe fatigue.
• Effects of the Central Nervous System ( CNS). Ayvakit is common with CNS side effects, and can be severe. Tell your health care provider if you have signs of new or deteriorating CNS, like

1.  Forgetting
2.  Trickery
3.  Perishing
4.  Tricky thought
5.  Drought
6. Schwindles
7. Sleeping troubles
8. Term Finding problems
9.  Seeing things or hearing stuff not present (hallucinations)
10. Mood change, or behavior change

• Your health care provider can temporarily stop your medication or reduce the dosage that may help improve your symptoms. If symptoms do not improve, the Ayvakit treatment may be permanently stopped by your health care provider.

The most frequent side effects include: ·

•          Retaining fluid or swelling
•          Boredom   
•        Fatigue
•          Muscle exhaustion
•           Spills
•          Hyperdiarrhea
•           Lowered appetite
•          Pain in the stomach (abdominal)
•          High tearing of the eye
•          Compulsion
•          Hurricane
•          Schwindles
•          Changes in hair colour

These are not all of Ayvakit's potential side effects. For medical advice on side effects contact the doctor. Side effects can be reported to FDA at 1-800-FDA-1088.

How store Ayvakit?

Place Ayvakit tablets at room temperature between 68 ° F and 77 ° F (20 ° C to 25 ° C).

Keep all medications out of the hands of children and pets.

General Information Use Of Ayvakit:

Drugs are often prescribed for reasons other than those in the patient knowledge leaflet. Do not take this medication for a disease for which it has not been prescribed. Don't give it to others, even if they have the same condition you have. It could harm them. You can ask your health care provider or pharmacist for more information to be provided to health professionals.

Contains Of Ayvakit:

• Ingredient for successful use: avapritinib

• Inactive ingredients: copovidone, sodium croscarmellose, stearate by magnesium, and cellulose by microcrystalline.

• Film coat: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Blue print ink: ammonium hydroxide, black iron oxide, esterified shellac, FD&C blue 1, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide.

DOSE:

Dosage suggested

AYVAKIT 's prescribed dosage is 300 mg orally once daily on an empty stomach, at least 1 hour before and 2 hours after a meal. Continue treatment before initiation of illness or excessive toxicity. Do not make up for the missed dose within 8 hours of the next scheduled dose. If vomiting occurs after AYVAKIT, do not take an additional dose, but proceed with the next scheduled dose.

Concomitant Use of Strong & Modrate CYP3A Inhibitors:

Avoid using AYVAKIT simultaneously with heavy or moderate CYP3A inhibitors. When concurrent use can not be prevented with a mild CYP3A inhibitor, raising the starting dose of AYVAKIT from 300 mg orally once daily to 100 mg orally once daily. to 100 mg orally once daily once daily.