ALIQOPA


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. 
 

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 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 you child during treatment with ALIQOPA. 

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

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

How will I recieve ALIQOPA?

  • ALIQOPA will be given to you by a healthcare provider as an intravenous (IV) injection into your vein over 1 hour.
  • You will receive your ALIQOPA treatment 1 time every week for 3 weeks and then stop for 1 week. This is 1 cycle of treatment. ALIQOPA is usually given on Day 1, Day 8, and Day 15 of a 28-day treatment cycle.
  • Your healthcare provider will decide how many treatment cycles you need.
  • Your healthcare provider may withhold treatment, decrease your dose, temporarily stop, or permanently stop treatment with ALIQOPA if you have certain side effects.

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.

What are the possible side effects of ALIQOPA?

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:
    • beaing very hungry
    • headache
    • being very thirsty
    • frequent urination
  • High bloode 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 treatent 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 severe skin reactions during treatment with ALIQOPA. 

The most common side effects of ALIQOPA include:

  • low white blood cell count (leukopenia)
  • low platelets in your blood (thrombocytopenia)
  • decreased strength and tiredness
  • lower reiratory tract infection
  • diarrhea
  • nausea
These are not all of the possible side effects of ALIQOPA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
 

General information about the safe and effective use of ALIQOPA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about ALIQOPA that is written for health professionals.
 

What are the ingredients in ALIQOPA?

Active ingredient: copanlisib
Inactive ingredients: citric acid anhydrous, mannitol, sodium hydroxide

Common symptoms of FL

The most common sighs of lymphoma start with painless swellings in the lymph nodes, particularly in the neck, underarms, or groin. Night sweats, fever, unexplained weight loss, fatigue, and other symptoms can also occur, mostly in advanced stages. Patients with FL are at particular risk of developing abdominal tumors that can obstruct normal digestion and urination. Because FL progresses slowly, the symptoms can fo unnoticed for years. 
 

Blood disorders - Coping and Choosing a Hematologist

Choosing a Hematologist

There are a handful blood disorders that impact you blood's ability to carry out its basic functions. Common blood disorders include aplastic anemia, blood clots, and blood cancers such as lymphoma and leukemia.
 
Hemotology is a branch of medicine that is concerned with the diagnosis and treatment of these blood disorders. If you think you may be suffering from a blood disorder, it is important you visit your primary care physician. If they find any abnormalities in your blood work, they may refer you to a hematologist. 
 

INDICATION

ALIQOPA (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION

Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis.

Hyperglycemia: Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.

Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia.

Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose.

Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).

Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg when concomitantly administered with strong CYP3A inhibitors.

 

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