Revcovi Revcovi Revcovi

Revcovi is the only FDA-approved enzyme replacement therapy indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

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WARNINGS AND PRECAUTIONS

  • Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
  • Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.

 

ADVERSE REACTIONS

The most commonly reported adverse reactions were cough (50%) and vomiting (33%).

In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in the treatment of ADA-SCID may also be seen with Revcovi treatment:

  • Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia, and autoimmune thrombocytopenia
  • Dermatological events: injection site erythema, urticaria
  • Lymphomas

 

IMPORTANT MONITORING INFORMATION

Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels for maintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely, and precautions should be taken to minimize the risk of infection.

 

INDICATION

Revcovi® (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information.

Ferriprox is an FDA-approved prescription medicine used to treat iron overload from blood transfusions in people with thalassemia syndromes, sickle cell disease, and other anemias.

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Ferriprox Ferriprox Ferriprox

Ferriprox is an FDA-approved prescription medicine used to treat iron overload from blood transfusions in people with thalassemia syndromes, sickle cell disease, and other anemias.

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Important Safety Information

Indication

Ferriprox® (deferiprone) is a prescription medicine used to treat iron overload from blood transfusions in people with:

  • thalassemia syndromes
  • sickle cell disease or other anemias

Ferriprox Tablets are for adults and children ≥8 years of age; Ferriprox Oral Solution is for patients ≥3 years of age.


It is not known if Ferriprox is safe and effective to treat iron overload due to blood transfusions:

  • in people with myelodysplastic syndrome or Diamond Blackfan anemia
  • in children less than 3 years of age

What is the most important information I should know about Ferriprox?

Ferriprox can cause serious side effects, including a very low white blood cell count.

One type of white blood cell that is important for fighting infections is called a neutrophil. If your neutrophil count is low (neutropenia), you may be at risk of developing a serious infection that can lead to death. Neutropenia is common with Ferriprox and can become severe in some people. Severe neutropenia is known as agranulocytosis. If you develop agranulocytosis, you will be at risk of developing serious infections that can lead to death.


Your healthcare provider will do a blood test before you start Ferriprox and regularly during treatment to check your neutrophil count. If you develop neutropenia, your healthcare provider should check your blood counts every day until your white blood cell count improves. Your healthcare provider may temporarily stop treatment with Ferriprox if you develop neutropenia or infection.


Stop taking Ferriprox and call your healthcare provider or get medical help right away if you develop any of these symptoms of infection: fever, sore throat or mouth sores, flu-like symptoms, or chills and severe shaking.


It is important for you to have your white blood cell count checked within 24 hours of developing symptoms of an infection to see if you have severe neutropenia (agranulocytosis). Do not delay getting medical care if you are unable to reach your healthcare provider.


Do not take Ferriprox if you are allergic to deferiprone or any of the ingredients in Ferriprox.


Before you take Ferriprox, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, are pregnant or plan to become pregnant. Ferriprox can harm your unborn baby. You should avoid becoming pregnant during treatment with Ferriprox. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ferriprox. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Ferriprox. You should use effective birth control during treatment with Ferriprox and for at least 6 months after the last dose. For males with female partners who are able to become pregnant, you should use effective birth control during treatment with Ferriprox and for at least 3 months after the last dose. Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if Ferriprox passes into your breast milk. Do not breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


Avoid drinking alcohol during treatment with Ferriprox tablets (2 times a day). This may cause a faster release of the medicine.


What are other possible side effects of Ferriprox?

Ferriprox can cause serious side effects, including increased liver enzyme levels in your blood. Your healthcare provider should do blood tests to check your liver function before you start and then monthly during treatment with Ferriprox. Your healthcare provider may temporarily stop treatment with Ferriprox if you develop increased liver enzyme levels and they continue to be increased.


Ferriprox can cause decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels during treatment with Ferriprox and may prescribe a zinc supplement for you if your zinc levels are low.


The most common side effects of Ferriprox in people with thalassemia include nausea, vomiting, stomach-area (abdominal) pain, joint pain, abnormal liver function tests, and low white blood cells.


The most common side effects of Ferriprox in people with sickle cell disease or other anemias include fever, stomach-area (abdominal) pain, bone pain, headache, vomiting, pain in arms or legs, sickle cell anemia with crisis, back pain, abnormal liver function tests, joint pain, mouth and throat pain, common cold, low white blood cells, cough, and nausea.


Ferriprox may cause a change in urine color to reddish-brown. This is not harmful and is expected during treatment with Ferriprox.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Please see Full Prescribing Information, including boxed WARNING, and Medication Guide.

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Ferriprox Logo Ferriprox Logo Ferriprox Logo

For the updated versions of the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), please refer to the EMA (European Medicines Agency) website.

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In accordance with the current legislation, we are unable to provide any information about our drugs concerning health issues. Anyone requiring these details should contact their treating physician.

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Procysbi Procysbi Procysbi

For the updated versions of the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), please refer to the EMA (European Medicines Agency) website.

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In accordance with the current legislation, we are unable to provide any information about our drugs concerning health issues. Anyone requiring these details should contact their treating physician.

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Lamzede Velmanase Alfa Lamzede Velmanase Alfa Lamzede Velmanase Alfa

For the updated versions of the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), please refer to the EMA (European Medicines Agency) website.

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In accordance with the current legislation, we are unable to provide any information about our drugs concerning health issues. Anyone requiring these details should contact their treating physician.

Raxone Raxone Raxone

For the updated versions of the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), please refer to the EMA (European Medicines Agency) website.

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In accordance with the current legislation, we are unable to provide any information about our drugs concerning health issues. Anyone requiring these details should contact their treating physician.

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