Iclusig

What is Iclusig?

Iclusig is a cancer drug that inhibits the growth of certain cancerous cells.Iclusig can be used for adults who have chronic phase myeloid leukemia and did not benefit from or tolerate treatment with two prior kinase-inhibitor medicines.

Iclusig can be used for adults who have accelerated or blast-phase CML or Philadelphia chromosome acute leukemia.Iclusig can also be used for adults who have a certain type of abnormal gene: T315I-positive, chronic-phase CML, accelerated-phase CML, blast-stage CML, or Ph+ ALL with T315I positivity.Iclusig should not be used to treat newly diagnosed CML in the chronic phase.Iclusig may be safe for children, but its effectiveness is unknown.

Warnings

Iclusig can cause problems with the heart and blood vessels that may lead to a heart attack or stroke.

If you experience chest pain that spreads to your shoulder or jaw, shortness of breath, dizziness, severe stomach pain, swelling in the legs, sudden numbness or weakness, headaches, or problems with vision or speech, call your doctor.

Iclusig can also damage your liver. If you experience upper abdominal pain, loss of appetite, dark urine, or bruising or yellowing skin or eyes, call your doctor immediately.

Before you take this drug

Iclusig should be avoided if you have an allergy to ponatinib.

Tell your doctor about any of the following to ensure that Iclusig will be safe for you:

• Hypertension and heart rhythm disorders;
• Long QT Syndrome
• A stroke or blood clot
• Diabetes;
• High Cholesterol
• Liver disease
• Bleeding problems;
• Lactose intolerance: Tablets containing lactose may cause lactose to be absorbed.
• Pancreatitis
• If you have had surgery in the last 2 weeks,

Before starting the treatment, you may be required to take a pregnancy test.Ponatinib can harm an unborn child. Pregnancy should be prevented by using effective contraception during the time you use this medication and at least three weeks after taking your last dose.

It is possible that this medicine can affect women's fertility. It is still important to avoid pregnancy by using birth control because Iclusig may harm the unborn child.Breastfeeding is not recommended while taking Iclusig or for 6 days following your last dose.

How to take Iclusig?

Follow the directions on your prescription label and read all medication guides or instructions sheets. Read all the instructions and directions that come with your medication. Sometimes your doctor will change the dose.Iclusig can be taken with or without meals, once a day.Do not chew or crush the tablet.

It may be necessary to have frequent tests done in order to ensure that the medicine you are taking isn't causing any harmful side effects. The results may delay your cancer treatment.Tell the surgeon that you will be undergoing surgery if you use Iclusig. It is possible that you will need to discontinue the medication at least one week prior to surgery.

You should not change the dose of Iclusig without consulting your doctor.Keep away from heat and moisture. Store at room temperature.

Details on dosage

Adult dose for chronic myelogenous leukemia:

The chronic phase of myeloid leukemia is also known as chronic phase chronic myeloid leukemia.
Initial Dose: 45 mg once daily orally
If BCR-ABL1 is less than 1% (standardized according to the International Scale), take 15 mg once daily.
For loss of response, re-escalate the dose to 30mg or 45 mg orally one time per day.
The following terms are used to describe the disease:
Initial dose: 45mg orally, once per day.
Comments:
For AP-CML (CML with pleocytosis), BP-CML (CML with pleocytosis), and Ph+ALL, the optimal dose is not yet known.
Consider reducing the dose for AP patients with CML who show a major cytogenetic reaction.
Continue treatment until there is no response to the drug or toxicity that you can tolerate.
If the patient hasn't responded to the drug within 3 months (90 days), then it is time to consider discontinuing use.
This medication is neither indicated nor recommended as a treatment for newly diagnosed chronic phase myeloid lymphoma (CP-CML).
Uses:
for the treatment of adults with CP/CML who have had at least two prior kinase inhibitors but are resistant to or intolerant to them.
For adult patients with AP CML, BP CML, Ph+ ALL, or BP CML for whom other kinase inhibitors are not indicated
For the treatment of adults with T315I-positive CML in any phase (chronic, accelerated, or blast) or T315I-positive Ph+ ALL

Adult dose for acute lymphoblastic leukemia:

The chronic phase of myeloid leukemia is also known as chronic phase chronic myeloid leukemia.
Initial Dose: 45 mg once daily orally
If BCR-ABL1 is less than 1% (standardized according to the International Scale), take 15 mg once daily.
For loss of response, re-escalate the dose to 30mg or 45 mg orally one time per day.
The following terms are used to describe the disease:
Initial dose: 45mg orally, once per day.
Comments:
The optimal dosage has not yet been determined for AP CML, BP CML, and Ph+ ALL.
Consider reducing the dose for AP patients with CML who show a major cytogenetic reaction.
Continue treatment until there is no response to the drug or unacceptable toxicities.
If the patient hasn't responded to the drug within 3 months (90 days), then it is time to consider discontinuing use.
This medication is neither indicated nor recommended as a treatment for newly diagnosed chronic phase myeloid lymphoma (CP-CML).
Uses:
for the treatment of adults with CP/CML who have had at least two prior kinase inhibitors but are resistant to or intolerant to them.
For adult patients with AP CML, BP CML, or Ph+ who do not require any other kinase inhibitors
For the treatment of adults with T315I-positive CML in any phase (chronic, accelerated, or blast) or T315I-positive Ph+ ALL

What happens if I miss the dose?

If you are almost due for the next dose, skip the missed one. Never take more than one dose at a time.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Grapefruit can interact with ponatinib, causing unwanted side effects. Grapefruit and grapefruit-based products should be avoided.

Side effects of Iclusig

If you experience any of the following symptoms of an allergy to Iclusig, seek immediate medical attention: itching, difficulty breathing, swelling in your lips, face, throat, or tongue.

Iclusig can cause blood vessels or heart problems, which could result in a heart attack or stroke. If you experience this, call your doctor or seek emergency medical attention.

• Symptoms of a heart attack: chest pressure or pain; spreading pain to the jaw or shoulder; feeling out of breath.
• Signs of stroke: sudden numbness, weakness, or headache (especially on one side), slurred or distorted speech, or problems with balance or vision;
• Signs of a Blood Clot: severe stomach pain, swelling, or pain in the arms and legs Coughing blood.

If you experience:

• Dizziness, confusion, headache, change in mental status;
• A seizure;
• Feeling short of breath, swelling, and rapid weight gain;
• A wound that does not heal.
• Eye problems: vision problems, pain in the eyes, swelling in the eyes, increased sensitivity to light, "floaters" or flashes in your vision, etc.
• Heart problems: chest pain, shortness of breath, fast or pounding heartbeats, and feeling as if you could pass out.
• A hole or tear in your stomach or in your intestine; severe pain in the stomach; and a fever
• Low Blood Cell Counts: Fever, Chills, Tiredness, Mouth Sores, and Skin Sores; Easy Bruising; Unusual Bleeding; Pale Skin; Cold Hands and Feet
• Nerve problems: tingling or burning in the hands and feet; muscle weakness.
• Severe bleeding: bloody or brown urine or bloody stools; heavy periods of menstruation; vomiting blood; or bloody vomit or vomit looking like coffee grounds.
• Signs of pancreas or liver problems include: loss of appetite (which may extend to the back), upper stomach pain, nausea, vomiting, rapid heartbeat, dark urine, and jaundice.

Iclusig is associated with the following side effects:

• Skin rash.
• Stomach pain, nausea, vomiting, diarrhea, and  constipation;
• Headache, joint, or muscle pain
• You may experience pain in the arms, legs, or feet.
• Increased blood pressure or
• Fever, fatigue

There may be other side effects. For medical advice on side effects, call your doctor. Report side effects by calling the FDA at 1-800-FDA-1088.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking.

Many medications can have an interaction with ponatinib. These include prescription drugs, over-the-counter medications, vitamins, and herbal products. This list does not include all interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.