IMPORTANT SAFETY INFORMATION

Infections: ALIQOPA can cause serious infections that may lead to death. The most common serious infection was pneumonia. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with ALIQOPA. 

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Aliqopa was demonstrated to work in relapsed patients similar to you

All of the patients with follicular lymphoma in the Aliqopa trial had already received at least 2 prior treatments.

What were the results of the study?

 

The study was designed to look at the overall response rate, which is the percentage of patients who responded to treatment.

 

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REMEMBER: Response rate is a term used for the portion of patients whose tumor shrank within a certain period of time.

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The Aliqopa clinical trial had 104 patients with follicular lymphoma. 59% of those patients responded to treatment (95% CI: 49, 68).

 

  • 14% of the patients in the trial showed a complete response
  • 44% of the patients showed a partial response

 

 

CI, confidence interval.

How long did patients respond?

The study was also designed to look at duration of response, which is how long patients responded to treatment.

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The median* length of treatment response was 12.2 months (range: 0+ to 22.6 months).

How long did it take for the cancer to respond?

The median* time it took the tumor to respond to Aliqopa was

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The median time to response was 1.7 months (range: 1.3 to 9.7 months).

 

*The median is the middle number in a group of numbers.

What is ALIQOPA?

ALIQOPA is a prescription medicine used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines.

 

It is not known if ALIQOPA is safe and effective in children.

 

ALIQOPA was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment. There is an ongoing study to confirm the benefit of ALIQOPA for this use.

 

 

IMPORTANT SAFETY INFORMATION

ALIQOPA can cause serious side effects, including:

Infections: ALIQOPA can cause serious infections that may lead to death. The most common serious infection was pneumonia. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with ALIQOPA.

 

High blood sugar (hyperglycemia): High blood sugar is common following ALIQOPA infusion and can sometimes be serious. Tell your healthcare provider if you develop any symptoms of hyperglycemia during treatment with ALIQOPA. Symptoms of hyperglycemia may include being very hungry, being very thirsty, frequent urination and headaches.

 

High blood pressure (hypertension): High blood pressure is common following ALIQOPA infusion and can sometimes be serious.

 

Lung or breathing problems: Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with ALIQOPA. Tell your healthcare provider right away if you develop new or worsening cough, shortness of breath, or difficulty breathing.

 

Low white blood cell count (neutropenia): Neutropenia is common with ALIQOPA treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment with ALIQOPA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with ALIQOPA.

 

Severe skin reactions: Skin peeling, rash, and itching are common with ALIQOPA and can sometimes be serious. Tell your healthcare provider if you develop skin peeling, itching, or rash during treatment with ALIQOPA. Your healthcare provider may withhold treatment, decrease your dose, or permanently stop treatment if you develop severe skin reactions during treatment with ALIQOPA.

 

Before receiving ALIQOPA, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • have lung or breathing problems
  • have high blood pressure (hypertension)
  • have diabetes or high blood sugar (hyperglycemia)
  • are pregnant or plan to become pregnant. ALIQOPA can harm your unborn baby.
    • Your healthcare provider will perform a pregnancy test before starting treatment with ALIQOPA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIQOPA.
    • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA.
  • are breastfeeding or plan to breastfeed. It is not known if ALIQOPA passes into your breast milk. Do not breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. Talk to your healthcare provider about the best way to feed your child during treatment with ALIQOPA.

 

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ALIQOPA works.

 

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

 

What should I avoid while receiving ALIQOPA?

  • Avoid taking St. John’s Wort during treatment with ALIQOPA.
  • Avoid drinking grapefruit juice during treatment with ALIQOPA.

 

The most common side effects of ALIQOPA include:

  • low white blood cell count (leukopenia)
  • low platelets in your blood (thrombocytopenia)
  • diarrhea
  • decreased strength and tiredness
  • lower respiratory tract infection
  • nausea

 

These are not all of the possible side effects of ALIQOPA. Call your doctor for medical advice about side effects.

 

For important risk and use information about ALIQOPA, please see the full  Prescribing Information.

 

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.


For Bayer products, you can report these directly to Bayer by clicking here.