Ultomiris (ravulizumab) for sale – Buy Ultomiris (ravulizumab) online
What is Ultomiris (ravulizumab) for?
Ultomiris (ravulizumab) is a complement inhibitor indicated to treat:
- Adults with paroxysmal nocturnal haemoglobinuria (PNH) who have symptoms indicating high disease activity as well as in patients who have been treated with eculizumab (another medicine for PNH and aHUS) for at least the past 6 months and have evidence that the treatment is working.
- Patients weighing at least 10 kg with atypical haemolytic uraemic syndrome (aHUS) who either have not received complement inhibitors (such as eculizumab) before or who have received eculizumab for at least 3 months and have evidence that the treatment is working.
It is available in vial form for intravenous infusion, containing 300 mg/10 mL (30 mg/mL) or 1,100 mg/11 mL (100 mg/mL) for faster infusion ravulizumab.[1,2]
How does Ultomiris (ravulizumab) work?
Ravulizumab, the active ingredient in Ultomiris, is a ‘complement inhibitor’. It can bind to and inhibit the C5 protein in the terminal complement cascade, which is part of the body’s immune system. In PNH and aHUS, the complement system is overactive (often because of a genetic mutation), which causes the development of disease. In PNH, this is seen as the breakdown of red blood cells, and in aHUS as the formation of blood clots in small blood vessels in the body.[1,2]
Where has Ultomiris (ravulizumab) been approved?
Ultomiris (ravulizumab) was approved by:
- The Food and Drug Administration (FDA), USA
- On December 21, 2018 for adults with PNH.[3]
- On October 18, 2019 for adults and children with aHUS.[4]
- On October 12, 2020 for a new 100 mg/mL formulation which will reduce infusion time by approximately 60 percent.[9]
- On June 7, 2021 for children (one month of age and older) and adolescents with PNH.[10]
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan:
- The European Medicines Agency (EMA), Europe:
Ultomiris (ravulizumab) was approved by the FDA under priority review and was previously granted Orphan Drug designation.[3]
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 Ultomiris (ravulizumab) taken?
The standard dosage depends on the patient’s body weight and can be found in the official prescribing information.[1,2]
Two weeks after the starting dose, the medicine is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight). For PNH, this is a life-long treatment. For aHUS, the medicine is given for at least 6 months but the doctor will consider the length of treatment for each patient individually.[1,2]
Complete information about Ultomiris (ravulizumab) dosage and administration can be found in the official prescribing information listed in our references section.[1,2]
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Ultomiris (ravulizumab)?
Common adverse reactions
The most common side effects ( ≥10% of patients) listed in the prescribing information include:[1,2]
- Diarrhoea
- Nausea (feeling sick)
- Vomiting
- Nasopharyngitis (inflammation of the nose and throat)
- Headache
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:[1,2]
- Infections, including meningococcal infection
Use in a specific population
It is now known if Ultomiris (ravulizumab) can cause harm to an unborn baby. It is advised to avoid breastfeeding and pregnancies. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Ultomiris and for 8 months after the last dose.[1,2]
Warning: Ultomiris is contraindicated in patients with unresolved Neisseria Meningitidis infection.[1,2]
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.[1,2]
References
1. Full prescribing information [FDA]: Ultomiris (ravulizumab) [PDF]
Alexion, Dec 2018
2. Full prescribing information [EMA]: Ultomiris (ravulizumab) [PDF]
Alexion, Jul 2019
3. FDA approves ravulizumab-cwvz for paroxysmal nocturnal hemoglobinuria
FDA press release, Dec 2018
4. Alexion Receives FDA Approval for ULTOMIRIS® (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (aHUS)
Press release, Oct 2019
5. ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Press release, Jun 2019
6. ULTOMIRIS® (ravulizumab) Receives Approval in Japan for Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Children
Press release, Sept 2020
7. ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Press release, Jul 2019
8. ULTOMIRIS® (ravulizumab) Receives Marketing Authorization from European Commission for Adults and Children with Atypical Hemolytic Uremic Syndrome (aHUS)
Press release, Jun 2020
9. Alexion Receives FDA Approval for New Advanced Formulation of ULTOMIRIS® (ravulizumab-cwvz) with Significantly Reduced Infusion Time
Press release, Oct 2020
10. Alexion Announces FDA Approval of ULTOMIRIS® (ravulizumab-cwvz) for Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Press release, Jun 2021
Reviews
There are no reviews yet.