Applies to omacetaxine: subcutaneous powder for solution.

Serious side effects of Omacetaxine

Along with its needed effects, omacetaxine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking omacetaxine:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• bloody nose
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• sore throat
• tingling of the hands or feet
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Incidence not known

• Arm, back, or jaw pain
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• confusion
• convulsions
• decreased urination
• deep, dark purple bruises
• difficulty with speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dry mouth
• fainting
• fast, shallow breathing
• fast, slow, pounding, or irregular heartbeat or pulse
• flushed, dry skin
• fruit-like breath odor
• headache
• hives, rash, or itching, pain, redness, or swelling of the skin
• hoarseness
• inability to move the arms, legs, or facial muscles
• inability to speak
• increased hunger
• increased thirst
• increased urination
• irritation
• joint pain, stiffness, or swelling
• loss of consciousness
• muscle cramps
• nausea
• nervousness
• pale, clammy skin
• pounding in the ears
• rapid breathing
• slow speech
• stomachache
• sunken eyes
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• thirst
• troubled breathing or swallowing
• unexplained weight loss
• vomiting of blood or material that looks like coffee grounds
• wrinkled skin

Other side effects of Omacetaxine

Some side effects of omacetaxine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• hair loss or thinning of the hair
• lack or loss of strength
• loss of appetite
• muscle pain or stiffness
• pain in the arms or legs
• trouble sleeping
• upper abdominal or stomach pain
• weight loss

Incidence not known

• Acid or sour stomach
• anxiety
• belching
• bleeding gums
• bloody eye
• bone pain
• burning, dry, or itching eyes
• continuous ringing or buzzing or other unexplained noise in the ears
• darkening of the skin
• decreased appetite
• depression
• double vision
• dry skin
• ear pain
• eye discharge or excessive tearing
• eye pain
• general feeling of discomfort or illness
• hearing loss
• heartburn
• increased sweating
• indigestion
• itching skin
• muscle spasm, stiffness, or weakness
• redness and swelling of the gums
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• stomach discomfort or upset
• stuffy nose

For Healthcare Professionals

Applies to omacetaxine: subcutaneous powder for injection.

General

The most common side effects (frequency greater than and equal to 20%) include thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia.

Serious side effects occurring in at least 5% of patients included febrile neutropenia (18%), thrombocytopenia (9%), anemia (7%), diarrhea (6%), and convulsions (6%).

The most common side effects leading to withdrawal were leukocytosis (6%) and thrombocytopenia (4%).^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, palpitations, acute coronary syndrome, angina pectoris, arrhythmia, bradycardia, ventricular extrasystoles, hematoma, hypertension, hot flush, hypotension, chest pain, general edema^[Ref]

Dermatologic

Very common (10% or more): Alopecia (15%), rash (10%)

Common (1% to 10%): Erythema, pruritus, dry skin, petechiae, hyperhidrosis, night sweats, ecchymosis, purpura, skin lesion, skin ulcer, rash erythematous, rash papular, skin exfoliation, skin hyperpigmentation^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 42%), nausea (up to 32%), constipation (15%), abdominal pain (up to 14%), vomiting (up to 15%)

Common (1% to 10%): Stomatitis, mouth ulceration, abdominal distension, dyspepsia, gastroesophageal reflux disease, gingival bleeding, aphthous stomatitis, dry mouth, hemorrhoids, gastritis, gastrointestinal hemorrhage, melena, mouth hemorrhage, oral pain, anal fissure, dysphagia, gingival pain, gingivitis^[Ref]

Genitourinary

Common (1% to 10%): Dysuria^[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (up to 74%), anemia (up to 61%), neutropenia (up to 50%), lymphopenia (17%), bone marrow failure (10%), febrile neutropenia (up to 20%)

Common (1% to 10%): Transfusion reaction

Frequency not reported: Pancytopenia, bone marrow necrosis^[Ref]

Hepatic

Frequency not reported: Elevated transaminases^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Metabolic

Very common (10% or more: Anorexia (13%)

Common (1% to 10%): Decreased appetite, diabetes mellitus, gout, dehydration

Frequency not reported: Hyperosmolar nonketotic hyperglycemia

Laboratory abnormalities (Grade 3 or 4): platelets decreased (up to 88%), neutrophils decreased (up to 81%), hemoglobin decreased (up to 80%), leukocytes decreased (up to 72%), uric acid increased (up to 57%), creatinine increased (up to 16%), glucose increased (up to 15%), bilirubin increased (up to 9%), glucose decreased (up to 8%), alanine aminotransferase (ALT) increased (up to 6%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (19%), pain in extremity (up to 13%), back pain (11%)

Common (1% to 10%): Bone pain, myalgia, muscular weakness, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, musculoskeletal discomfort^[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)

Common (1% to 10%): Dizziness, cerebral hemorrhage, paresthesia, convulsion, hypoesthesia, lethargy, sciatica, burning sensation, dysgeusia, tremor

Frequency not reported: Cerebral hemorrhage^[Ref]

Ocular

Common (1% to 10%): Cataract, blurred vision, conjunctival hemorrhage, dry eye, increased lacrimation, conjunctivitis, diplopia, eye pain, eyelid edema^[Ref]

Other

Very common (10% or more): Infections (bacterial, viral, fungal and nonspecified) and infestations (up to 56%), infusion and injection site related reactions (up to 34%), fatigue (up to 31%), pyrexia (up to 29%), asthenia (up to 24%), peripheral edema (13%), chills (13%)

Common (1% to 10%): Ear pain, ear hemorrhage, tinnitus, mucosal inflammation, pain, hyperthermia, influenza-like illness, catheter site pain, malaise, contusion

Frequency not reported: Multi-organ failure^[Ref]

Psychiatric

Very common (10% or more): Insomnia (10%)

Common (1% to 10%): Anxiety, depression, agitation, confusional state, mental status change^[Ref]

Respiratory

Very common (10% or more): Cough (up to 16%), epistaxis (up to 15%), dyspnea (11%)

Common (1% to 10%): Pharyngolaryngeal pain, nasal congestion, dysphonia, productive cough, rales, rhinorrhea, hemoptysis, sinus congestion^[Ref]