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CUVITRU: What You Need to Know

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CUVITRU: What You Need to Know

Cuvitru (generic name: immune globulin) is derived from human plasma, and it is given to patients with antibody deficiencies to protect against infections.

This medicine belongs to the immune globulins drug class. Cuvitru is FDA approved [1] to be used as a monotherapy or adjunct therapy with other medications.

 

Speak to a Specialist – Cuvitru Copay Assistance

 

 

Cuvitru Treatment/Therapy

Cuvitru is an immunoglobulin solution that is administered via subcutaneous infusion only.  It works by replacing antibodies that are not functioning properly or not present in the human body to help fight off infections. FDA-approved doses are given to increase extremely low blood immunoglobulin levels to required levels [2].

Cuvitru is Indicated for:

  • Primary Humoral Immunodeficiency (PI) in adults and pediatric patients 2 years and older (people with inborn lack of antibody generation).
  • Blood cancer patients with little antibody production and recurring infections when preventative antibiotics can’t be used [3].
  • Bone marrow cancer patients and those who lack antibody production with repeated infections.
  • Decreased levels of antibodies following transplantation of bone marrow cells from another patient.

 

Cuvitru Side Effects

Allergic Reaction Symptoms:

  • Rash
  • Hives
  • Itching
  • Red and swollen skin 
  • Fever 
  • Shortness of breath 
  • Wheezing
  • Chest tightness,
  • Trouble breathing
  • Swelling of face and lips

Cuvitru Questions? Free Consult Available

 

 Symptoms Requiring Urgent Medical Attention:

  • Weakness
  • Fever
  • Bruising
  • Chills
  • Sore throat
  • Seizures
  • Bloating
  • Swelling
  • Confusion
  • Abnormal heart rate
  • Mood swings
  • Speech abnormalities
  • Increased sweating
  • Vision abnormalities
  • Belly pain
  • Dark urine
  • Yellow skin or eyes

Urination Abnormalities:

  • Difficulty passing urine
  • Blood in urine
  • Frequent urination
  • Weight gain

Elevated or Decreased Blood Pressure: 

  • Headache
  • Dizziness
  • Blurred vision

Respiratory Infections and Inflammation Such As:

  • Asthma bronchitis
  • Sinusitis
  • Rhinitis

Aseptic Meningitis (May Require Immediate Medical Attention):

  • Headache
  • Fever
  • Chills
  • Upset stomach
  • Vomiting
  • Stiff neck
  • Light sensitivity

Injection Site Reactions:

  • Itching 
  • Redness of the skin
  • Mild discomfort [7]

These injection site reactions usually don’t require medical attention and go away within a few hours.

Injection site reactions are less likely to occur after repeated use as the body gets adjusted to the drug.

 

Blood Clot Risk Factors

Cuvitru has a Black Box Warning due to the possibility of causing blood clots.

Patients are at increased risk of having blood clots if they have one or more of the following risk factors:

  • Advanced age 
  • Sedentary lifestyle 
  • Hypercoagulable conditions 
  • History of previous blood clots  
  • Estrogen use

There may be other factors, and patients are encouraged to discuss them with their doctor.

To help prevent or reduce the risk of blood clots, the manufacturer recommends infusing at the minimum dose and lowest infusion rate possible. Monitor signs and symptoms during and after the treatment.

 

Cuvitru Dosing

Cuvitru Is administered under the skin (subcutaneously), typically by a trained healthcare professional. 

Dosing varies from patient to patient.

Factors That Influence Dosing Calculations:

  • Body weight
  • Blood IgG levels
  • Medical history
  • Current conditions
  • Clinical response to the treatment

Based on the these factors, the patient (a child or adult) may be prescribed a loading dose of at least 1.0-2.5 ml/kg of body weight divided over a few consecutive days [8]. 

Following this loading dose, patients will start to receive Cuvitru at regular intervals from daily to once every two weeks.  

The total monthly dose will be between 1.5-5.0 ml/kg of bodyweight after the loading dose.  

The doctor may adjust the dose over time to achieve the desired clinical response and serum IgG levels. 

For patients who are switching from another IVIG brand, the Cuvitru dose will be based on the previous IVIG dose and will be adjusted according to the number and frequency of infusion. 

It is not recommended to make changes to the dose or dosing interval without talking to the doctor. 

If you miss a dose, it is important to speak to the doctor as early as possible and get a new dosing schedule. Avoid doubling the dose to catch up.

 

Home Infusion Available

 

Cuvitru Injection Sites

Cuvitru Uses 

Cuvitru is Used to Treat: 

 In addition, Cuvitru is used to boost muscle strength in patients with multifocal motor neuropathy (MMN). 

 

Cuvitru Cost/Price

The cost of Cuvitru treatment varies depending on various factors, such as:

  • The insurance provider
  • The prescribed dosage
  • Dispensing pharmacy

This medication is supplied in single-dose glass vials that typically contain 5 ml, 10 ml, 20 ml, 40 ml, and 50 ml protein per vial.

The base cost displayed on different pharmacies’ websites is set by the Cuvitru manufacturer, Takeda Pharmaceutical, exclusive of shipping costs and any local tax. 

Depending on the dispensing pharmacy, the price of Cuvitru is nearly $210 (almost $42 per unit) for a supply of 5ml, making the total price for 50ml about $2,100 [9].

 

Copay Assistance

Pharmaceutical companies generally sponsor different patient assistance programs (PAPs) to offer free or discounted medications to people who otherwise cannot pay for their medications.

Takeda’s OnePath Co-Pay Assistance Program is one such program. It provides dedicated support to patients who have been prescribed Cuvitru [10] [11]. Patients must be commercially insured to enroll in this program. 

This program covers certain out-of-pocket treatment costs and assists with navigating the health insurance process. In-house training from trained staff and education and support services are also available.

In addition, HelloCUVITRU is a free trial program that covers the entire cost of the first four infusions of Cuvitru, together with supplies required for administration [12]. To be eligible for this program, a patient must be 2 years or older, who was not previously enrolled in this program and is currently not using Cuvitru.

 

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REFERENCES:

[1] “CUVITRU | FDA,” U.S. Food & Drug Administration, [Online]. Available: https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/cuvitru.
[2] “Immunoglobulin Replacement Therapy – Australasian Society of Clinical Immunology and Allergy,” Australasian Society of Clinical Immunology and Allergy, [Online]. Available: https://www.allergy.org.au/patients/immunodeficiencies/immunoglobulin-replacement-therapy.
[3] “Clinical Trials Using Therapeutic Immune Globulin – National Cancer Institute,” National Cancer Institute, [Online]. Available: https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/therapeutic-immune-globulin.
[4] “Cuvitru Advanced Patient Information – Drugs.com,” Drugs.com, [Online]. Available: https://www.drugs.com/cons/cuvitru.html#side-effects.
[5] “Kidneys (Anatomy): Picture, Function, Conditions, Treatments,” WebMD, [Online]. Available: https://www.webmd.com/kidney-stones/picture-of-the-kidneys.
[6] “Breathing Problems: Causes, Tests, & Treatments,” WebMD, [Online]. Available: https://www.webmd.com/lung/breathing-problems-causes-tests-treatments#1.
[7] “Cuvitru Subcutaneous: Uses, Side Effects, Interactions, Pictures,” WebMD, [Online]. Available: https://www.webmd.com/drugs/2/drug-172578/cuvitru-subcutaneous/details.
[8] “Cuvitru- Lexicomb.com [online]. 
[9] “Cuvitru Prices, Coupons and Patient Assistance Programs,” Drugs.com, [Online]. Available: https://www.drugs.com/price-guide/cuvitru.
[10] “Takeda OnePath Assistance Program,” Takeda, [Online]. Available: https://www.takeda.com/en-ca/what-we-do/helping-canadian-patients/onepath-assistance-program/.
[11] “OnePath Support for CUVITRU,” CUVITRU, [Online]. Available: https://www.cuvitru.com/support-and-resources/onepath.
[12] “HelloCUVITRU Free Trial Program,” Cuvitru, [Online]. Available: https://www.cuvitru.com/support-and-resources/hello-cuvitru.

 

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