Osimert 80 mg (Osimertinib)

Osimert 80 mg is a third-generation oral inhibitor of EGFR tyrosine kinase (TKI) in NSCLC with EGFR T790M resistance mutation. It has been approved for use in first-line and maintenance therapy in patients with NSCLC with locally advanced or metastatic disease. It specifically attacks the EGFR-mutated cells and tumor growth in normal tissues.

It shows strong penetration in the central nervous system and works well against metastases in the brain, a frequent complication in EGFR-mutated NSCLC. 

There has been significant improvement in progression-free and overall survival compared to earlier EGFR TKIs. Clinical trials. 

With a good safety profile and better efficacy, Osimert 80 mg offers a hopeful treatment option for eligible NSCLC patients.

How It works

The function of Osimert 80 mg is to inhibit a certain pathway of transmission that aids the cancer cells in growth. It works on a cancer-causing mutation in the epidermal growth factor receptor (EGFR) called T790M. It is an anti-cancer medication that works by slowing or stopping the growth of cancer cell in the body by reducing the action of an abnormal protein. This particular mutation is known as the Epidermal Growth Factor Receptor (EGFR) T790M. Which causes cancer cells to grow uncontrollably despite using other targeted therapy.

It is one of the most resistant mutations among other NSCLC mutations. This targeted therapy works brilliantly here, targeting this specific mutation without destroying other healthy cells beside the tumor. Because of the ability to target specific mutations in the NSCLC, it has fewer side effects and more efficacy than other traditional chemotherapy drugs.

Regulatory Approvals

Everest Pharma has gained confidence in the international pharmaceutical market by regularity in adherence to regulatory guidelines and quality parameters. Its products have been approved by the national health authorities of Bangladesh (DGDA), Nepal (DDA), and Pakistan (DRAP)—these demand comprehensive information relating to safety, efficacy, and the quality of the product.

What sets Everest apart is its dedication to maintaining regulatory readiness. The company routinely submits bioequivalence data, ICH-guided stability reports, and manufacturing validations as part of its dossier submissions. For countries with stringent requirements, Everest either obtains direct registration or works with licensed partners who support regulatory bridging through mutual recognition agreements.

Everest achieves full pharmacovigilance compliance by actively monitoring post-market safety data and reporting adverse events as per international protocols. 

Indications in Medical Use

Conditions it Treats

Depending on the active molecule, Osimert 80 mg may be prescribed 

• For patients with EGFR-mutated non-small cell lung cancers.
• For patients whose tumors exhibit certain molecular alterations, confirmed through biopsy testing. 
• It also can be relevant in managing malignancies of the central nervous system (CNS) when there is a concern of brain metastases, due to its ability to cross the blood-brain barrier.

However, its use outside of lung cancer is off-label and guided by clinical judgment and available evidence.

Who is it for?

Doctors use Osimert 80 mg for adults to treat advanced or metastatic non-small cell lung cancer in patients who have positive results for EGFR mutation testing. The mutations include exon 19 deletion and T790M; other mutations are not indicated for use. A biopsy test or a blood test must be done to identify the mutation.

This drug is given after prior therapies that do not control the malignancy or in previously untreated patients. Activity against central nervous system metastases is a prominent feature of this drug, because this agent readily crosses into the central nervous system and maintains its activity there. You will need proper testing and evaluation before starting this treatment.

Dosage and Administration

• Osimert 80 mg Take one tablet by mouth once daily with or without food. 
• Whole swallowing is required—do not crush, split, or chew the tablet. 
• Keep this medicine out of reach of children. Store at room temperature. 
• Time of administration: Recommended to be taken at around the same time each day with a full glass of water. 
• It is advised not to take more or less of the drug or take it more frequently than prescribed by your doctor. Do not skip doses or stop taking the medicine without consulting your doctor.
• Adhere to the exact instructions of your doctor. Don’t change doses or stop taking the medicine without checking first, even if you think you are feeling better. The drug is more effective if taken regularly.
• Also, avoid taking grapefruit or grapefruit juice while being treated with the pill, as it may give rise to some undesirable effects due to altered metabolism of the medication.

What if I miss a dose?

Missed dose: If you miss a dose and it has been less than 12 hours, take the dose as soon as you remember. If more than 12 hours have passed since your last dose, skip the missed dose and take the next one at the regular time. Do not double the dose.

If you have any doubt in your mind or if you are on many medications, you may even want to check with your doctor. The medication works best when a regular schedule is kept.

Side Effects

This medication can cause mild to severe side effects depending on patients health condition, medical history or history of other disease.

Common side effects:

• Increased risk of infection: fever, muscle aches, headache, feeling cold, shivering and tired
• Bruising, bleeding gums or nosebleeds
• Diarrhea
• Skin problems include skin rashes, dry skin and itching
• Mouth ulcers
• Anorexia
• Stomach-ache
• Nausea, vomiting
• Back-ache
• Headache
• Pain, discoloration, infection, or other problems with fingernails or toenails.

Rare side effects:

• Hives
• Increased blood creatinine levels
• Thinning hair or complete hair loss
• Inflammation and scarring of lung tissue causing difficulty breathing, coughing or high fever
• Redness and peeling of the hands and feet (called hand-foot syndrome or plantar fasciitis)
• Swelling of the face, lips, tongue, or throat.

Call your doctor right away if you notice the following rare side effects:

• Rash, blistering or peeling of the skin.
• Heart problems such as changes in heart function (QTc prolongation) or heart failure causing shortness of breath, rapid or pounding heartbeat, chest pain, etc.
• Keratitis causes eye pain, watery eyes, sensitivity to light, blurred vision, and red eyes.
• Cutaneous vasculitis causes bruises or skin rashes on the arms, legs, buttocks, or all over the body.
• Nail problems, including swelling around the nail, brittle nails, dryness, pain, discoloration, or ridges. The skin around the nail becomes swollen, red, painful, or infected.
• Swelling of the ankles or feet.
• Feels like I might pass out.
• Persistent fever, bruising or bleeding, pale skin, unusual tiredness or weakness, or any other signs of infection.

• Osimert 80 mg can cause serious side effects like problems with heart, lungs, and eye vision. If you feel any of that immediately call your doctor and inform them.

• Your doctor may ask you to stop treatment temporarily or permanently or reduce the dose of the medication depending on the side effects you experience. 

However the information above only for general purpose, always follows your doctor’s prescription before taking the drug.

Warnings and Precautionary Advice for Osimert 80 mg

Monitoring Needs

• Patients taking 80 mg of Osimert should receive routine medical checks to ensure safety and efficacy. Such checks may include assessments involving blood tests for white cells, kidney function, liver function, and electrolyte levels. In addition, patients’ lungs and hearts should be monitored with ECG tests, especially for those who have heart problems.
• Any such symptoms as shortness of breath, chest pain, and changes in vision should be reported to the healthcare provider without delay.
• Taking Osimert 80 mg, avoid grapefruits and grapefruit products since these may interfere with the metabolism and efficacy of the drug.
• Alcohol and smoking should be avoided as they may stress the liver, though stopping is strongly recommended.
• A healthy diet with more fruits, vegetables, and lean protein would be good for overall well-being in the treatment.
• Regular hydration and light physical activities are also advisable for the patients to keep their strength high.

Use During Pregnancy and Breastfeeding

Potential Risks

Do not take Osimert 80 mg tablet while you are pregnant because this medicine may cause harm to your baby. Results of preclinical studies have shown evidence of embryo-fetal toxicity. This medication may also cause fetal harm when given to a pregnant woman. Women of childbearing potential should use effective contraception during treatment and for a reasonable time thereafter in order to avoid the risk of becoming pregnant. 

Breastfeeding is not allowed within a certain time before and after the administration so that the infant does not get chemicals. Preclinical studies have evidence that patients contain chemicals in breast milk. 

Safer Alternatives

If required for the patient based on her condition and the stage of cancer, the healthcare provider can make a decision for treatment with alternatives that are safer during pregnancy or breastfeeding. 

In some cases, healthcare providers may consider recommending therapy that is not as aggressive or waiting to treat for a certain time. 

Multidisciplinary medical advice from oncologists and obstetricians is important during the treatment.

Special Populations and Adjusted Dosing

Elderly Patients

There is no need for a regular dose adjustment in the elderly population based solely on age. However, since age often comes with the concomitant problems of reduced organ function, the condition may react to how well the drug is metabolized and tolerated.

It is to be ensured that regular monitoring is done to see if the conditions, such as cardiac or pulmonary complications, are more explicit in the geriatric population.

Kidney or Liver Impairment

Mild to moderate renal impairment does not require dose adjustment. The caution is, however, observed when administering the drug to patients with severe renal impairment and ESRD.

Dosage adjustment is unnecessary in patients with liver dysfunction and in mild liver impairment. The drug should be administered cautiously in patients with moderate to severe hepatic impairment due to the significant impact of liver function on drug metabolism.

Pharmacotherapeutics

EGFR Inhibitor Class

Osimert 80 mg is part of the third generation of inhibitors of the receptor of the epidermal growth factor (EGFR), which has mutations in the gene-specific EGFR called the T790M resistance mutation or the 19p deletion.

Contrast with Other Targeted Therapies

In comparison with other first-generation targeted therapies such as erlotinib and gefitinib, the Osimert 80 mg tablet works much more effectively and precisely in treating the T790M mutation. Other therapies fail to break down the cancer growth and disease progression, but this drug does so with precision.

 It has better penetration across the blood-brain barrier, leading to a solution for brain metastases as well.

Storage and Handling Instructions

Temperature Guidelines

Store Osimert 80 mg tablets at 20°C to 25°C (68°F to 77°F). Keep them in a dry place away from heat and direct sunlight. Keep out of the reach of children and in the original package.

Proper Disposal

Do not flush or throw away the unused or expired tablets. Instead, follow local medical guidelines for disposal. Many communities or pharmaceutical companies offer take-back programs; if it is not available, consult a healthcare provider or pharmacist for the disposal of the medication.

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Onus Pharma places patient safety and confidence above everything else by ensuring to provide 100% real and certified medicines, including Osimert 80 mg. All our products come from reputable, authorized producers and go through rigorous quality controls before they are sent out. We apply international pharmaceutical standards fully in all our operations, and every order comes with easily checked documents like batch numbers and analysis certificates for your assurance.

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The price of Osimert 80 mg can vary depending on factors such as location, availability, and supplier. As a specialized cancer treatment, it’s important to source this medication from a trusted pharmaceutical provider to ensure authenticity and quality.

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