Important Safety Information

 

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated

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Indication


ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.

Access

ADAKVEO Patient Support

ADAKVEO Support at PANO

ADAKVEO Support at PANO

ADAKVEO Support at PANO, part of Patient Assistance Now Oncology (PANO), is a support center consisting of insurance specialists and case managers who help patients access their medication and provide information regarding patient support programs. Dedicated support specialists help direct callers to the programs that best fit your patients’ needs.

 

To Enroll Patients

The Service Request Form (SRF) is now customizable to your patient's medication. The SRF is a single form with 2 parts:

  • One part to be completed by the patient
  • One part to be completed by the health care professional (HCP)

Both parts must be fully completed and submitted to open a case. ADAKVEO Support at PANO will then match the 2 parts and contact the HCP to initiate next steps.

To learn more, call 1-800-282-7630 or visit HCP.Novartis.com/Access/.

ADAKVEO Connect

ADAKVEO Connect Patient Program

Case coordinators, who have a social work background, will provide support to your eligible patients and their caregivers and connect them to third-party resources as needed.

Case Coordinators can provide:
  • Insurance coverage guidance: Inform patients on the process for insurance approval and provide status updates. Help guide health care professionals on the process for enrolling patients into the ADAKVEO Support at PANO
  • Drug and disease education: Provide education about ADAKVEO and offer disease education
  • Case management: Help identify barriers to disease management for patients, and suggest local and national resources to support patients as needed

To learn more, call 1-800-282-7630 or to start the enrollment process for your patients, please complete the SRF form available at HCP.Novartis.com/Access/.

Universal Co-pay Program

At Novartis Oncology, we’ve made it easy for patients with private insurance to access financial support for their prescription costs for almost all Novartis Oncology medications.

* Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, please visit Copay.NovartisOncology.com or call 1-877-577-7756.

Service Request Form is not required.

ADAKVEO Access Program

The ADAKVEO Access Program helps eligible patients start therapy quickly

In the event of a qualifying pre-certification denial and resulting delay in your patient’s insurance coverage, the ADAKVEO Access Program will make product available to eligible patients for a US Food and Drug Administration–approved indication when program requirements are met.

No purchase of ADAKVEO is required. ADAKVEO is provided to qualifying patients, new to ADAKVEO therapy, free of charge. The ADAKVEO Access Program is limited to drug sufficient for up to a maximum of 4 treatments. The ADAKVEO Access Program is available to patients with all insurance types.

Novartis cannot guarantee that every patient who enrolls in ADAKVEO Support at PANO will be successful in obtaining insurance coverage for treatment or will receive financial assistance.

To learn more about this support program and patient eligibility, or to enroll your patient, please call 1-800-282-7630

Indication

ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.

Important Safety Information

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Laboratory Test Interference: Platelet Counts

Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.

Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

Pregnancy

Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).

Other Clinically Important Adverse Reactions

Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

Please see full Prescribing Information.