Buy Lucaftor (lumacaftor/ivacaftor) Online

Description

What is Lucaftor (lumacaftor/ivacaftor) for?

Lucaftor (lumacaftor/ivacaftor) is a medication that is released immediately upon being ingested, used for treating cystic fibrosis (CF) in patients who are 12 years old and above and have two copies of the F508del mutation (F508del/F508del) in the CFTR gene. The medication is available in tablet form, containing 100 mg lumacaftor and 125 mg ivacaftor. The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina, has authorized Lucaftor as a biosimilar of Orkambi (lumacaftor/ivacaftor). A biosimilar product is highly similar to an already approved medicine, providing an equivalent level of quality, safety, and efficacy to a brand-name medicine.

How does Lucaftor (lumacaftor/ivacaftor) work?

The cystic fibrosis transmembrane conductance regulator (CFTR) is an ion channel protein that plays a role in maintaining salt and water balance on the surface of the lung. It is situated on the surface of epithelial cells in various organs, including the lungs. In patients with cystic fibrosis, mutations in the CFTR gene trigger the production of defective protein that is also expressed less on cells. Consequently, the cell surface dries up, making the mucus covering the lung cells thick and sticky. Consequently, mucus gets trapped in the airways, germs multiply, and infections result. Lumacaftor boosts the function of the malfunctioning CFTR protein and enhances its availability on the cell surface. Ivacaftor, on the other hand, is a CFTR potentiator that can open the ion channel, thereby, helping to maintain salt and water balance on the lung surface. Since lumacaftor and ivacaftor work directly on the CFTR protein, they act directly on the root cause of CF.

How is Lucaftor (lumacaftor/ivacaftor) taken?

The recommended dosage for Lucaftor (lumacaftor/ivacaftor) is as follows: two tablets (each containing 200 mg lumacaftor and 125 mg ivacaftor) to be taken orally every 12 hours, with food containing fat. This amounts to a total daily dose of 800 lumacaftor and 500 mg ivacaftor. However, the dosage may need to be adjusted based on symptoms and any encountered side effects. For further details on dosage and administration, kindly refer to the official prescribing information in our references section. It is essential to seek advice from your doctor in regards to personalized dosing and any potential drug interactions.

Are there any known side effects of Lucaftor (lumacaftor/ivacaftor)?

Yes, there are known side effects of Lucaftor (lumacaftor/ivacaftor) which can affect some patients. Some common side effects may include shortness of breath, chest tightness, coughing up blood, fever, flu-like symptoms, headache, nausea, and diarrhea. Other possible side effects may include liver problems, cataracts, and increased blood pressure. It is important to immediately report any unusual symptoms or side effects to your doctor while taking Lucaftor (lumacaftor/ivacaftor). It is recommended to consult with your doctor first for any questions or concerns about potential side effects and how to manage them.

Use in a specific population

Lucaftor (lumacaftor/ivacaftor) should not be used by pregnant or breastfeeding women as it can be harmful to the fetus. To avoid potential risks, it is advised to take necessary precautions and avoid pregnancy during the course of treatment. For further details about adverse reactions and side effects, please consult the official prescribing information.

Clinical trials

The ANMAT approval of Lucaftor (lumacaftor/ivacaftor) for the treatment of homozygous F508del-CFTR COPD patients aged 12 years and older was based on a comparative phase study conducted in a specific population. In a single-center, open-label, randomized-sequence, single-dose, two-way, crossover bioequivalence study, 42 healthy adult subjects received two tablets of lumacaftor/ivacaftor (200/125mg) twice daily, with minimization of assignment bias by administering either Lucaftor-Reference or Reference-Lucaftor at the dosing moments. The results showed that Lucaftor is similar to the reference product in terms of rate and extent of absorption, as well as tolerability and safety. The data demonstrated therapeutic equivalence and interchangeability of Lucaftor to the reference product, with expected similar clinical results.