Side effects requiring immediate medical attention with Selumetinib

During treatment with Selumetinib, in addition to its expected therapeutic effects, this medication may cause some adverse effects. While not all side effects occur, some may require medical intervention.

Side effects requiring immediate medical attention with Selumetinib

1. Common side effects

Blisters, crusting, irritation, itching, or reddening of the skin; blood in the urine; cracking, dryness, or peeling of the skin; diarrhea; fast heartbeat; itching, pain, redness, swelling, tenderness, or warmth on the skin; loosening of the fingernails; muscle or bone pain; nosebleeds; redness or pain around the nails; swelling.

2. Uncommon side effects

Blurred vision; changes in vision; difficulty or labored breathing; dizziness; headache; nervousness; seeing unusual halos around lights; pounding sensation in the ears; rapid weight gain; seeing flashes or sparks of light; seeing floating spots in the field of vision, or a curtain-like obstruction covering part of the visual field; slow or fast heartbeat; tightness in the chest.

Other side effects of Selumetinib

Some side effects of Lucius Pharmaceuticals Selumetinib usually do not require medical attention and may gradually resolve as your body adjusts to the medication. Additionally, your healthcare professional may be able to suggest ways to prevent or reduce some of these side effects.

Side effects requiring medical consultation with Selumetinib

Common side effects

Constipation; fever; hair loss or thinning hair; loss of appetite; nausea; stomach pain; swelling or inflammation of the mouth; unusual tiredness or weakness; vomiting.

Side effect management for healthcare professionals

1. Overall adverse events

The most common adverse reactions (incidence ≥40%) include: vomiting, rash (all types), abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia (fever), acneiform rash, stomatitis, headache, paronychia, and pruritus.

2. Cardiovascular system

Very common (≥10%): Decreased ejection fraction (up to 23%), sinus tachycardia (20%), increased blood pressure and hypertension (<20%).

3. Skin system

Very common (≥10%): Rash (all types) (up to 91%), dry skin (60%), acneiform rash (50%), paronychia including nail infection (48%), pruritus (46%), dermatitis (36%), hair changes (32%), skin infection (20%).

Other events reported in studies (frequency not listed): Palmar-plantar erythrodysesthesia syndrome.

The most common types of rash included acneiform dermatitis (54%), maculopapular rash (39%), and eczema (28%). Rash (all types) encompasses: acneiform dermatitis, maculopapular rash, erythema, pustular rash, rash, urticaria, exfoliative rash, pruritic rash, erythematous rash. Acneiform rash specifically refers to acneiform dermatitis. Dermatitis includes: atopic dermatitis, diaper dermatitis, eczema, seborrheic dermatitis, skin irritation. Hair changes include: alopecia, hair color changes. Skin infection includes: abscess, cellulitis, impetigo, and staphylococcal skin infection.

4. Digestive system

Very common (≥10%): Vomiting (82%), abdominal pain (76%), diarrhea (up to 77%), nausea (up to 73%), stomatitis including mouth ulcers (50%), constipation (34%), increased lipase (32%), dry mouth (<20%), increased amylase (18%).

Other events reported in studies (frequency not listed): Perforation, colitis, ileus, intestinal obstruction.

5. Hematologic system

Very common (≥10%): Decreased albumin (51%), decreased hemoglobin (41%), neutropenia (33%), lymphopenia (20%).

6. Hepatobiliary system

Very common (≥10%): Increased aspartate aminotransferase (AST) (41%), increased alanine aminotransferase (ALT) (35%).

7. Metabolic system

Very common (≥10%): Increased blood potassium (27%), decreased appetite (22%), weight gain (<20%), decreased blood potassium (18%), increased alkaline phosphatase (18%), increased blood sodium (18%), decreased blood sodium (16%).

8. Musculoskeletal system

Very common (≥10%): Increased creatine phosphokinase (up to 79%), musculoskeletal pain including pain in extremities, back, and neck (58%).

Other events reported in studies (frequency not listed): Rhabdomyolysis.

9. Nervous system

Very common (≥10%): Headache (48%).

10. Ocular system

Very common (≥10%): Visual impairment including blurred vision, photophobia, cataract, and increased intraocular pressure (<20%).

Other uncommon events reported in studies (0.1% to 1%): Retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), central serous retinopathy (CSR).

11. Other

Very common (≥10%): Fatigue and asthenia/weakness (56%), pyrexia (fever) (56%), generalized and localized edema including peripheral swelling (20%), facial and periorbital edema (<20%).

12. Respiratory system

Very common (≥10%): Epistaxis (nosebleed) (28%), dyspnea including exertional and at rest (<20%).

13. Renal system

Very common (≥10%): Hematuria (blood in urine) (22%), proteinuria (protein in urine) (22%), acute kidney injury (<20%).