Abeclib 150 Tablet 1 Strip

✔️ Adverse Effects | Abeclib 150 Tablet

Very Common (>10%) – Monotherapy

• Increased serum creatinine
• Diarrhea
• Decreased white blood cells and neutrophils
• Anemia
• Fatigue
• Nausea
• Reduced appetite
• Thrombocytopenia
• Abdominal pain
• Vomiting
• Infections
• Elevated ALT and AST
• Headache
• Constipation
• Arthralgia
• Alopecia
• Dizziness
• Pyrexia

Very Common (>10%) – Combination Therapy

• Increased creatinine
• Leukopenia and neutropenia
• Diarrhea
• Anemia
• Lymphopenia
• Thrombocytopenia
• Fatigue
• Nausea and vomiting
• Infections
• Elevated liver enzymes
• Decreased appetite
• Headache
• Dysgeusia
• Alopecia
• Stomatitis
• Peripheral edema
• Rash

✔️ Dosage & Administration | Abeclib 150 Tablet

Adult Dosage

Breast Cancer

Abeclib is indicated in the following settings:

• As monotherapy in HR+/HER2− advanced or metastatic breast cancer with disease progression following endocrine therapy
• In combination with fulvestrant for patients with disease progression after endocrine therapy
• In combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with HR+/HER2− advanced or metastatic breast cancer

Recommended Doses

Monotherapy

Abemaciclib 200 mg orally twice daily

Continue until disease progression or unacceptable toxicity

Combination with Aromatase Inhibitor

Abemaciclib 150 mg orally twice daily

Aromatase inhibitor: as per prescribing information

Continue until disease progression or unacceptable toxicity

Combination with Fulvestrant

Abemaciclib 150 mg orally twice daily

Fulvestrant 500 mg intramuscularly on Days 1, 15, and 29, followed by once monthly

Continue until disease progression or unacceptable toxicity

Hepatic Impairment

Mild to moderate (Child-Pugh A or B): No dose adjustment required

Severe (Child-Pugh C): Reduce dosing frequency to once daily

Renal Impairment

Mild to moderate renal impairment (CrCl 30–89 mL/min): No dose adjustment required

Severe renal impairment, ESRD, or dialysis: Not studied

✔️ Drug Interactions

Ketoconazole: Avoid coadministration

Other strong CYP3A inhibitors: Dose reduction required

Strong CYP3A inducers: Avoid coadministration

✔️ Pregnancy, Lactation & Fertility

Pregnancy

There are no adequate human data. Based on animal studies and its mechanism of action, abemaciclib may cause fetal harm when administered during pregnancy. Pregnancy testing is recommended prior to initiation. Women of reproductive potential should use effective contraception during treatment and for at least 3 weeks after the last dose.

Lactation

It is unknown whether abemaciclib is excreted in human breast milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding should be discontinued during treatment and for 3 weeks after the final dose.

Fertility

Animal studies suggest potential impairment of male fertility.

✔️ Precautions & Warnings

Venous Thromboembolism (VTE)

Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, and other serious venous occlusions, have been reported in patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant. Patients should be monitored closely for signs and symptoms of thromboembolism, and appropriate treatment should be initiated if necessary.

Hepatotoxicity

Elevations in liver transaminases have been observed during therapy.

Median onset of Grade ≥3 ALT elevation: ~57 days

Median onset of Grade ≥3 AST elevation: ~185 days
Regular liver function monitoring is recommended.

Neutropenia

Neutropenia has been reported, with Grade ≥3 neutropenia typically occurring within the first month of treatment. Febrile neutropenia is rare but serious cases, including fatal neutropenic sepsis, have been reported.

Diarrhea

Diarrhea is very common and typically occurs early in treatment, often within the first month. Severe diarrhea may lead to dehydration and infection. Prompt management with antidiarrheal therapy and dose adjustment is recommended.