Imkeldi

Pronunciation: Im-KELL-Dee
Generic name: imatinib
Dosage form: oral solution 80 mg/mL
Drug class: BCR-ABL tyrosine kinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 27, 2024.

What is Imkeldi?

Imkeldi is used to treat specific types of leukemia (blood cancer), bone marrow disorders, dermatofibrosarcoma protuberans (a rare type of skin cancer), and certain tumors of the stomach and digestive system.

• Imkeldi (imatinib) is an oral solution taken 1 or 2 times a day.

Imkeldi’s mechanism of action involves targeting BCR-ABL tyrosine kinase and some other kinases, particularly ones responsible for uncontrolled cell growth. By preventing these enzymes from working properly, Imkeldi slows cancer growth and spread. Imkeldi belongs to the drug class BCR-ABL tyrosine kinase inhibitors.

Imkeldi gained FDA approval on November 22, 2024. Imkeldi is the only oral solution formulation of imatinib mesylate available, and there is no Imkeldi generic. Gleevec is another imatinib brand name that is available as an oral tablet. Gleevec is available as a generic under the name imatinib mesylate. 

Imkeldi uses

Imkeldi is used to treat:

• Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase in newly diagnosed adult and children
• Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy
• Relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in adults
• Newly diagnosed Ph+ ALL in children in combination with chemotherapy
• Myelodysplastic/myeloproliferative diseases (MDS/MPD) in adults associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements
• Aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown in adults
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) in adults with the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown
• Unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) in adults
• Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) and adjuvant treatment of adults following resection of Kit (CD117) positive GIST.

Is Imkeldi chemotherapy?

No, Imkeldi is not chemotherapy, it is a targeted treatment that primarily targets BCR-ABL tyrosine kinase as well as other kinases, which are enzymes responsible for uncontrolled cell growth. Imkeldi is often used alongside chemotherapy.

Imkeldi side effects

The most common Imkeldi side effects are:

• fluid retention;

• nausea, vomiting, stomach pain, diarrhea;

• joint or muscle pain;

• skin rash; or

• feeling tired.

Serious side effects and warnings

Imkeldi can cause the following serious side effects.

Fluid retention and edema. Contact your healthcare provider if unexpected rapid weight gain occurs.

Imkeldi may increase the risk of liver problems. Tell your doctor if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Imkeldi can lower blood cells that help your body carry oxygen, fight infections, or clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Imkeldi may increase the risk of developing heart failure or heart problems. The risk is higher in those with other medical conditions and risk factors for cardiovascular disease. Tell your doctor if you have swelling or rapid weight gain, shortness of breath, fast or slow heart rate, weak pulse, or fainting.

Imkeldi may also cause perforations (holes) in your gastrointestinal tract, low thyroid levels, severe skin reactions, a decrease in how well your kidneys work, and a life-threatening condition called tumor lysis syndrome that happens when cancer treatment causes cancer cells to die quickly.

Imkeldi may harm an unborn baby. 

Imatinib can affect growth in children and teenagers. The long-term effects of prolonged treatment with Imkeldi on growth in children are unknown. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Imkeldi may cause drowsiness, dizziness, or blurred vision, and affect your ability to drive a car or operate machinery.

Get emergency medical help if you have signs of an allergic reaction to Imkeldi (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain;

• kidney problems--little or no urination, swelling in your feet or ankles;

• fluid build-up in the lungs--pain when you breathe, wheezing, gasping for breath, cough with foamy mucus;

• liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• low blood cell counts--fever, cold or flu symptoms, easy bruising, unusual bleeding, mouth sores, pale skin, unusual tiredness, feeling light-headed, cold hands and feet;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth; or

• thyroid symptoms--tiredness, dry skin, hair loss, constipation, depression, slow heart rate, weight gain, feeling more sensitive to cold temperatures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Imkeldi if you are allergic to imatinib, imatinib mesylate, Imkeldi, Gleevec, or any of the inactive ingredients in the oral solution.

Tell your healthcare provider if you have ever had:

• liver disease (especially hepatitis B);

• kidney disease;

• underactive thyroid, recent or upcoming thyroid surgery;

• heart disease, high blood pressure, congestive heart failure;

• a stomach ulcer or bleeding;

• diabetes; 

• chemotherapy.

Tell your healthcare provider about all the medicines you take, especially antibiotics and iron supplements.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Imkeldi if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 14 days after your last dose.

Do not breastfeed a baby while you are using Imkeldi and for at least 1 month after your last dose.

How should I take Imkeldi?

Take Imkeldi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You must measure Imkeldi with an accurate milliliter measuring device.

• A household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions.
• Ask your pharmacist to recommend an appropriate press-in bottle adapter and oral dispensing syringe and for instructions for measuring the correct dose (an oral dispensing syringe is not included with Imkeldi).
• Wear disposable gloves while preparing, withdrawing, taking, or giving Imkeldi to avoid direct contact with the medicine.
• See the Imkeldi Package Insert for detailed Instructions for Use.

The dose of Imkeldi should be taken with a meal and a large glass of water. Do not take Imkeldi on an empty stomach.

Imkeldi dosing information

See the Imkeldi Prescribing Information for more detailed dosing information, including dosage modifications for liver or kidney disease, or with drug interactions.

Usual Adult Imkeldi Dose for Ph+ CML CP, AP, or BC 

• Chronic phase: Imkeldi 400 mg orally once a day
• Accelerated phase or blast crisis: Imkeldi 600 mg orally once a day
  
  A dose increase may be considered under certain circumstances (see the Prescribing Information).

Usual Child Imkeldi Dose for Ph+ CML CP 

• Imkeldi 340 mg/m² (not to exceed 600 mg).

Can be given as a once-daily dose or the daily dose may be split into two–one portion doses in the morning and one portion in the evening.

There is no experience with Imkeldi treatment in children under 1 year of age.

Usual Adult Imkeldi Dose for Relapsed or Refractory Acute Ph+ ALL  

• Imkeldi 600 mg orally daily

Usual Child Imkeldi Dose for Ph+ ALL

• Imkeldi 340 mg/m²/day (not to exceed 600 mg).

Can be given as a once-daily dose. 

Usual Adult Imkeldi Dose for MDS/MPD

• Imkeldi 400 mg orally once a day

Determine PDGFRb gene rearrangement status before initiating therapy.

Usual Adult Imkeldi Dose For ASM

• Imkeldi 400 mg orally once a day

See the Prescribing Information for detailed dosing.

Usual Adult Imkeldi Dose for HES/CEL 

-For patients with HES/CEL: Imkeldi 400 mg orally daily
-For patients with HES/CEL with demonstrated FIP1L1-PDGFR alpha fusion kinase: Imkeldi 100 mg orally daily; dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Usual Adult Imkeldi Dose for DFSP

• Imkeldi 800 mg orally once a day.

Usual Adult Imkeldi Dose for Metastatic and/or Unresectable GIST

• Imkeldi 400 mg orally once a day.

A dose increase may be considered. See the Prescribing Information for detailed dosing.

Usual Adult Imkeldi Dose for Adjuvant GIST

• Imkeldi 400 mg orally once a day.

Related/similar drugs

Blincyto, omeprazole, methotrexate, lansoprazole, Prilosec, hydroxyurea, Revlimid, Prevacid, cyclophosphamide, imatinib

What happens if I miss a dose?

Take your dose as soon as you can, making sure you also eat a meal and drink a large glass of water. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Imkeldi may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Grapefruit may interact with Imkeldi and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What other drugs will affect Imkeldi?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can have interactions with Imkeldi, especially:

• an antibiotic, antifungal, or antiviral medicine;

• seizure medicine;

• a blood thinner such as warfarin (Coumadin, Jantoven); or

• a vitamin or mineral supplement that contains iron.

Imkeldi and certain other medicines, such as warfarin, erythromycin, and phenytoin, including over-the-counter medications, such as herbal products, can interact with each other. Advise patients to tell their doctor if they are taking or plan to take iron supplements. Avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking Imkeldi [see Drug Interactions (7)

This list is not complete and many other drugs may interact with imatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Imkedli ingredients

Active: 80 mg imatinib present as 95.57 mg imatinib mesylate

Inactive Ingredients: acesulfame potassium, citric acid monohydrate, glycerine, liquid maltitol, purified water, sodium benzoate, strawberry flavor (artificial flavors, lactic acid, triacetin). 

Imkeldi oral solution 80 mg/mL is supplied as 140 mL of clear yellow to brownish-yellow colored solution with a strawberry flavor in an amber PET bottle with a child-resistant tamper-evident closure.  

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C) away from moisture and heat.

Imkeldi comes in a child-resistant tamper-evident bottle. Store and give in original bottle only.

Any opened Imkeldi bottle should be thrown away (discarded) 30 days after first opening.

Talk to your healthcare provider or pharmacist about the best way to throw away any unused Imkeldi. Follow all special handling and throw-away (disposal) procedures provided by your healthcare provider and pharmacist.  

Keep out of the reach of children. 

Who makes Imkeldi?

Shorla Oncology Inc. manufactures Imkeldi.

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Further information

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