Lucaftor (lumacaftor/ivacaftor)

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What is Lucaftor (lumacaftor/ivacaftor) for?

Lucaftor (lumacaftor/ivacaftor) is an immediate-release medication used for the treatment of cystic fibrosis (CF) in patients 12 years and older who have two copies of the F508del mutation (F508del/F508del) in the CFTR gene. It is available in tablet form containing 100 mg lumacaftor and 125 mg ivacaftor.^[1]

Lucaftor is a biosimilar of Orkambi (lumacaftor/ivacaftor) that has been approved by the National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina.. A biosimilar is a biopharmaceutical product that is highly similar to a medicine that has been already approved. It has the same quality, safety and efficacy as the brand-name medicine.^[1]

How does Lucaftor (lumacaftor/ivacaftor) work?

The cystic fibrosis transmembrane conductance regulator (CFTR) is a type of protein called an ion channel. Ion channels are involved in keeping the balance of salt and water in the surface of the lung. It is present on the surface of epithelial cells in various organs, including the lungs.^[2]

In CF patients, mutations in the CFTR gene lead to the production of a dysfunctional protein that is also expressed less on the cells. This causes the cell surface to dehydrate, and as a result the mucus covering lung cells will become thick and sticky. Mucus will get stuck in the airways, and the germs trapped in the mucus will multiply and cause infections.^[3]

Lumacaftor improves the function of the dysfunctional CFTR protein, and helps increase its availability on the cell surface.^[2]

Ivacaftor is a CFTR potentiator that is able to open the ion channel. Thereby, it helps to maintain the salt and water balance in the lung surface.^[2]

Lumacaftor and ivacaftor both work directly on the CFTR protein, and thereby act directly on the underlying cause of CF.^[2]

Where has Lucaftor (lumacaftor/ivacaftor) been approved?

Lucaftor (lumacaftor/ivacaftor) was approved for the maintenance treatment of COPD patients aged 12 years and older who are homozygous for the F508 deletion in the CFTR gene by:

• ANMAT on September 23, 2017.^[4]

It’s reference form containing 200 mg lumacaftor and 125 mg ivacaftor was approved by the Food and Drug Administration (FDA) for the treatment of CF in patients 2 years of age and older with homozygous F508del-CFTR.^[5]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Lucaftor (lumacaftor/ivacaftor) taken?

The standard dosage is:^[1]

• 400 mg lumacaftor and 250 mg ivacaftor

Two tablets (each containing 200 mg lumacaftor and 125 mg ivacaftor) are taken orally every 12 hours with fat-containing food. The total daily dose is 800 lumacaftor and 500 mg ivacaftor.

Reduction in dose may be required based on symptoms and experienced side effects.

Complete information about Lucaftor (lumacaftor/ivacaftor) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

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

Common adverse reactions

The most common adverse reactions (≥20% of patients) listed in the prescribing information include:^[1]

• Breathing problems such as shortness of breath and chest tightness
• Nausea
• Diarrhea
• Fatigue
• Increase in a certain blood enzyme called creatine phosphokinase
• Rash
• Gas
• Common cold, including sore throat, stuffy or runny nose
• Flu or flu-like symptoms
• Irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Worsening of liver function in people with severe liver disease
• High liver enzymes in the blood
• Breathing problems such as shortness of breath or chest tightness
• An increase in blood pressure
• Abnormality of the eye lens (cataract)

Use in a specific population

Lucaftor (lumacaftor/ivacaftor) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

References

1. Summary of Product Characteristics [ANMAT]: Lucaftor (lumacaftor/ivacaftor) [PDF](Spanish)
Gador, Sept 23, 2017

2. Lumacaftor-ivacaftor in the treatment of cystic fibrosis: design, development and place in therapy
Connett GJ, Drug Des Devel Ther, Jul 19, 2019

3. CFTR: cystic fibrosis and beyond
Mall MA, European Respiratory Journal, 2014

4. ANMAT press release [PDF](Spanish)
published on Sept 23, 2017

5. FDA Approvals Orkambi (lumacaftor/ivacaftor)
Press release, July 2, 2015