How can you help your patients reconnect?

Patients with PI taking CUVITRU may be able to experience more of these moments with weekly or every-other-week infusions.¹

Information for starting your patients on CUVITRU

Once a treatment decision has been made, there are different options for getting your patients started on treatment:

Acquire CUVITRU directly for infusion in your clinic
Find a specialty pharmacy provider in network that supplies CUVITRU
Utilize Takeda Patient Support to coordinate treatment access

The information provided below can help ensure your patients are equipped with everything they need for an optimal administration experience.

Packaging, Storage & Handling

CUVITRU is supplied in single-use vials

CUVITRU is supplied in single-use vials containing the labeled amount of functionally active IgG. The components used in the packaging for CUVITRU are not made with natural rubber latex.¹

The following presentations of CUVITRU are available:

NDC Number	VOLUME
0944-2850-01	5 mL
0944-2850-03	10 mL
0944-2850-05	20 mL
0944-2850-07	40 mL
0944-2850-09	50 mL

NDC Number	GRAMS PROTEIN
0944-2850-01	1.0
0944-2850-03	2.0
0944-2850-05	4.0
0944-2850-07	8.0
0944-2850-09	10.0

NDC Number	VOLUME	GRAMS PROTEIN
0944-2850-01	5 mL	1.0
0944-2850-03	10 mL	2.0
0944-2850-05	20 mL	4.0
0944-2850-07	40 mL	8.0
0944-2850-09	50 mL	10.0

Storage and handling¹

Store at refrigeration temperature: 2°C to 8°C
[36°F to 46°F] for up to 36 months OR room temperature: not to exceed 25°C [77°F] for up to 24 months
Do not return CUVITRU to the refrigerator if you take it out to room temperature
Do not freeze

Do not shake
Keep the vials in the carton in order to protect from light
Discard any unused product
Do not use past the expiration date

Pump & Tubing Supplies

Achieving an optimal administration experience requires appropriate supplies¹

The following information is intended to assist HCPs in selection of appropriate equipment in order to achieve the maximum infusion rate of 60 mL/h/site with CUVITRU. Takeda does not prefer, recommend, or attest to using any specific infusion pump or other ancillary devices. For the first two infusions of CUVITRU, the recommended infusion rate is 10-20 mL/hr/site. For subsequent infusions, the infusion rate may be increased to 60 mL/hr/site as tolerated (e.g., 60 mL/hr/site x 2 sites = 120 mL/hr).

Follow each infusion pump’s manufacturer guidelines before use and administration.

RMS Freedom Infusion System^2,3
Freedom60^® Pump
- - Precision™ Flow Rate Tubing:
  - F180
- - Infusion Rate (1 site):
  - 11.59 mL/hr
- - Infusion Rate (2 sites):
  - 6.00 mL/hr
- - Precision™ Flow Rate Tubing:
  - F275
- - Infusion Rate (1 site):
  - 17.07 mL/hr
- - Infusion Rate (2 sites):
  - 8.99 mL/hr
- - Precision™ Flow Rate Tubing:
  - F500
- - Infusion Rate (1 site):
  - 28.63 mL/hr
- - Infusion Rate (2 sites):
  - 15.66 mL/hr
- - Precision™ Flow Rate Tubing:
  - F600
- - Infusion Rate (1 site):
  - 33.21 mL/hr
- - Infusion Rate (2 sites):
  - 18.45 mL/hr
- - Precision™ Flow Rate Tubing:
  - F900
- - Infusion Rate (1 site):
  - 45.28 mL/hr
- - Infusion Rate (2 sites):
  - 26.20 mL/hr

- - Precision™ Flow Rate Tubing:
  - F1200
- - Infusion Rate (1 site):
  - 55.34 mL/hr
- - Infusion Rate (2 sites):
  - 33.19 mL/hr
- - Precision™ Flow Rate Tubing:
  - F2400
- - Infusion Rate (1 site):
  - N/A
- - Infusion Rate (2 sites):
  - 55.27 mL/hr
- High-Flo Subcutaneous Safety Needle Sets™
- 24 g high-flow needle sets

EMED SCiG Infusion System^4,5
SCIg60 Infuser™ Pump
- - Infuset™ Flow Rate Tubing:
  - Infuset™ 190
- - Infusion Rate (1 site):
  - 11.59 mL/hr
- - Infusion Rate (2 sites):
  - 6.00 mL/hr
- - Infuset™ Flow Rate Tubing:
  - Infuset™ 290
- - Infusion Rate (1 site):
  - 17.07 mL/hr
- - Infusion Rate (2 sites):
  - 8.99 mL/hr
- - Infuset™ Flow Rate Tubing:
  - Infuset™ 430
- - Infusion Rate (1 site):
  - 28.63 mL/hr
- - Infusion Rate (2 sites):
  - 15.66 mL/hr
- - Infuset™ Flow Rate Tubing:
  - Infuset™ 650
- - Infusion Rate (1 site):
  - 33.21 mL/hr
- - Infusion Rate (2 sites):
  - 18.45 mL/hr
- - Infuset™ Flow Rate Tubing:
  - Infuset™ 820
- - Infusion Rate (1 site):
  - 45.28 mL/hr
- - Infusion Rate (2 sites):
  - 26.20 mL/hr

- - Infuset™ Flow Rate Tubing:
  - Infuset^™ 930
- - Infusion Rate (1 site):
  - 55.34 mL/hr
- - Infusion Rate (2 sites):
  - 33.19 mL/hr
- - Infuset™ Flow Rate Tubing:
  - Infuset^™ 1850
- - Infusion Rate (1 site):
  - N/A
- - Infusion Rate (2 sites):
  - 55.27 mL/hr
- Soft-Glide™ Needle Sets
- 24 g high-flow needle sets

Specialty Pharmacy

Working with your specialty pharmacy provider

When getting started on therapy, your patients will receive CUVITRU from a specialty pharmacy provider (SPP). Here are some considerations when working with an SPP:

Is CUVITRU covered under the pharmacy or medical benefit? This will impact how your office acquires CUVITRU and is reimbursed
Check the patient’s health plan to see which SPPs are covered (see authorized list below)
Avoid substitution by having the healthcare provider specify “dispense as written” (DAW) on the CUVITRU prescription
If the SPP form doesn’t have CUVITRU listed, clearly write it on the form
Confirm that the appropriate tubing, ancillaries, and/or accompanying medications are dispensed alongside CUVITRU

Find an authorized CUVITRU SPP

Patient’s prescribed CUVITRU may receive it from an SPP. Check your patient’s insurance coverage to determine which SPP is within your patient’s network.

The following SPPs are authorized to dispense CUVITRU:

Inquire with specific SPPs for current status.

All product brands or trademarks are the property of their respective owners.

Printable version of SPP providers available

Download

Review safety information

Review Important Safety Information, including contraindications and other specific warnings and precautions to consider when prescribing and monitoring patients treated with CUVITRU.

See safety information

Comparable coverage to other PI treatments

Coverage requirements for CUVITRU may vary by plan. Take advantage of the insurance resources available to help your patients get timely access to CUVITRU.

Learn about access support options

Dosing & Administration

Access & Support

Contact a Rep

IMPORTANT SAFETY INFORMATION including BOXED WARNING for Thrombosis

INDICATION

CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS

Thrombosis may occur with immune globulin (IG) products, including CUVITRU. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
For patients at risk of thrombosis, administer CUVITRU at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Contraindications

History of anaphylactic or severe systemic hypersensitivity reactions to subcutaneous administration of human IG.
IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human IG.

Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur with intravenous (IV) use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to starting infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: CUVITRU contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because CUVITRU is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with CUVITRU.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

Adverse Reactions

The most common adverse reactions observed in clinical trials in ≥5% of patients were: local adverse reactions including mild or moderate pain, erythema, and pruritus, and systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.

Drug Interactions

Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

Please click for Full Prescribing Information.