Information for US patients

Hello world!

December 12, 2022
|In Uncategorized
|By info@optimusdesign.co.uk
Indication and Important Safety Information
Tascenso ODT Logo
Indication and Important Safety Information
Tascenso Logo
Indications

TASCENSO ODT is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

Contraindications

Do not take TASCENSO ODT if:

  • In the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure;
  • You have an irregular or abnormal heartbeat (arrhythmia), including a heart finding called prolonged QT as seen on an ECG, or if you take medicines that change your heart rhythm.
  • You are allergic to fingolimod or any of the other ingredients.

Important Safety Information

Warnings and Precautions

TASCENSO ODT may cause serious side effects. TASCENSO ODT can slow your heart rate, therefore you will be monitored after the first dose. There is an increased risk of serious infections, some of which can be life threatening; contact your doctor if you develop any symptoms of infections. You may experience shortness of breath and increased blood pressure. Progressive multifocal leukoencephalopathy, a rare brain infection, has occurred in patients taking fingolimod; call your doctor immediately if you experience symptoms including weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack may occur; call your doctor immediately if you have any vision changes. TASCENSO ODT may cause liver damage; call your doctor immediately if you experience unexplained nausea, abdominal pain, fatigue, anorexia, jaundice and/or dark urine. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod; call your doctor immediately if you experience sudden onset of severe headaches, altered mental status, visual disturbances or seizures. TASCENSO ODT may cause harm to your unborn baby; speak to your doctor before becoming pregnant. Stopping TASCENSO ODT may cause worsening of your MS symptoms, consult a doctor before stopping treatment. Malignancies have been associated with fingolimod treatment; limit exposure to sunlight and call your doctor if you have any changes in skin appearance. You may experience a hypersensitivity reaction; call your doctor if you experience rash, urticaria and angioedema. TASCENSO ODT remains in the blood and can continue to have effects up to two months after treatment.

Adverse Reactions

The most common side effects with fingolimod are headache, abnormal liver tests, diarrhea, cough, flu, inflammation of the sinuses, back pain, stomach pain, and pain in arms and legs.

If you have any new or worsening negative side effects whilst taking TASCENSO ODT you should immediately call your doctor.

Tell your doctor about all your medical conditions and all medicines you take, before starting treatment.

If you take too much TASCENSO ODT immediately call your healthcare provider or go to the nearest hospital emergency room.

For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/PI.

For more detailed information, please refer to the Medication Guide – www.tascenso.com/MG.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

TASCENSO ODT®

©2023 Cycle Pharmaceuticals Limited. All rights reserved.

TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC.

Cycle Vita is a trademark of Cycle Pharmaceuticals Limited in the United States.

Contact us
Cycle Pharma Logo
Contact us
Cycle Vita Logo
Contact us
Follow us

@TascensoODT

@TascensoODT

@CycleVitaUSA

Cycle Vita USA

Compliance & Policies
Accessibility statement

US-FIN-2200018 | Date of Preparation: January 2023