Sotoxen (Sotorasib) 120 MG – 56 Tablets

Description

Sotoxen (Sotorasib), generic Lumakras, is a prescription medicine used to treat metastatic non-small cell lung cancer that has spread to other parts of the body or cannot be removed by surgery received at least one other treatment. Sotorasib is in a class of medications called KRAS inhibitors. 

Generic Name: Sotorasib INN

Brand Name: Sotoxen

Available Strengths: 120 Mg

Manufacturer: Everest Pharmaceuticals Ltd

Packaging Size: 56 Tablets

Pharmacology Of Sotorasib

Mechanism of Action: 

Sotorasib is a potent and highly selective KRASG12C (Kirsten rat sarcoma viral oncogene homolog) inhibitor which covalently and irreversibly binds to the unique cysteine of KRASG12C. Inactivation of KRASG12C by Sotorasib blocks tumour cell signalling and survival, inhibits cell growth, and promotes apoptosis selectively in tumours harbouring KRASG12Can oncogenic driver of tumorigenesis across multiple cancer types. The potency and selectivity of Sotorasib are enhanced through the unique binding to both the P2 pocket and the His95 surface groove, locking the protein in an inactive state that prevents downstream signalling without affecting wild-type KRAS.

Sotorasib demonstrated in vitro and in vivo inhibition of KRASG12C with minimal detectable off-target activity against other cellular proteins and processes. Sotorasib impaired oncogenic signalling and tumour cell survival at clinically relevant exposures in numerous pre-clinical models expressing KRASG12C. Sotorasib enhanced antigen presentation and inflammatory cytokine production only in tumour cells with KRASG12C. Sotorasib induced anti-tumour inflammatory responses and immunity, driving permanent and complete tumour regressions in immunocompetent mice implanted with KRASG12C expressing tumours. 

Indication and Usage

Sotorasib is indicated for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer(NSCLC), as determined by an FDA-approved test who have received at least one prior systemic therapy. 

Dosage and Administration 

 The recommended dosage of Sotorasib is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.

Take Sotorasib at the same time every day, with or without food. The tablets should be swallowed whole. Avoid chewing, crushing, or splitting tablets. If you miss a dose of Sotorasib by more than 6 hours, take the next dose as prescribed the next day. Do not consume two doses simultaneously to make up for a missed dose.

If vomiting occurs after taking Sotorasibdo, do not take an additional dose. The next day, take the prescribed dose. Swallowing solids with difficulty is a common problem among patients with swallowing difficulties.

Make a solution of 120 ml (4ounces) of non-carbonated water at room temperature without crushing the tablets. It would be best if you did not use any other liquids. Stir until tablets are dispersed into small pieces (the tablets won’t completely dissolve) and drink immediately or within two hours. The mixture may appear pale yellow or bright yellow. Swallow the tablet dispersion. Chewing tablet pieces is not recommended. Ensure the tablets are dispersed by rinsing the container with 120 ml (4 ounces) of water and drinking the mixture. If the mixture is not consumed, stir it again to ensure dispersion.

Dosage Modifications for Adverse Reactions:

Sotorasib dose reduction levels are summarized in Table 1. Dosage modifications for adverse reactions are provided in Table2. If adverse reactions occur, a maximum of two dose reductions are permitted. Discontinue SOTORASIB if patients cannot tolerate the minimum dose of240 mg once daily. 

Precautions of Sotorasib

If you have any allergies, tell your doctor or pharmacist before taking Sotorasib. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, inform your doctor or pharmacist about your medical history, especially of liver problems.

Tell your doctor or dentist about all the products you use (including prescription, non-prescription, and herbal).

During pregnancy, this medication should be used only when needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for one week after the last dose. Consult your doctor before breastfeeding.

Consult your pharmacist or physician. 

Interactions 

Drug interactions may change how your medications work or increase your risk for serious side effects. Drug interactions are not covered in this document. Keep a list of all your products (including prescription/non-prescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Other medications can affect the removal of Sotorasib from your body, which may affect how Sotorasib works. Examples include rifamycins (such as rifabutin) and drugs used to treat seizures (such as carbamazepine and phenytoin).

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include lonafarnib, certain products used to treat chronic hepatitis C (asunaprevir, ombitasvir/paritaprevir/ritonavir). 

Overdose

Call your doctor if someone has overdosed and has serious symptoms such as passing out or trouble breathing. 

Do not share this medication with others. Lab and medical tests (such as liver function, complete blood count, and blood mineral levels) should be done while taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. 

Missed Dose 

If you miss a dose, take it as soon as you remember unless it is more than 6 hours after the time you usually take the dose. In that case, skip the missed dose. Take your next dose at a regular time. Do not double the dose to catch up. 

Storage 

Store at room temperature away from light and moisture. Do not store it in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. 

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