Abemaciclib 50mg, 100mg, 150mg Film Coated Tablets — CDK4/6 Inhibitor for HR-Positive HER2-Negative Breast Cancer in Combination With Endocrine Therapy and as Monotherapy
Ramiven® (Abemaciclib) — CDK4/6 Inhibitor With Continuous Daily Dosing and Proven Overall Survival Benefit
The Only CDK4/6 Inhibitor Approved as Monotherapy and the Only One With Continuous Twice-Daily Dosing — Proven OS Benefit in HR-Positive Breast Cancer
Ramiven® (Abemaciclib) is a selective, potent cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor used in combination with endocrine therapy for hormone receptor-positive (HR+) HER2-negative advanced or metastatic breast cancer — and as monotherapy for HR-positive HER2-negative metastatic breast cancer after prior endocrine therapy and chemotherapy. Abemaciclib inhibits CDK4 and CDK6 — blocking retinoblastoma protein (Rb) phosphorylation and preventing cell cycle progression from G1 to S phase — arresting cancer cell division and inducing senescence.
Abemaciclib is the third approved CDK4/6 inhibitor in its class — alongside Palbociclib (Palbace) and Ribociclib (Kryxana) — but is distinguished by three important characteristics: it is the only CDK4/6 inhibitor approved as single-agent monotherapy, it uses a continuous twice-daily dosing schedule (rather than 3-weeks-on/1-week-off), and it has demonstrated significant overall survival benefit in the adjuvant setting (monarchE trial) — the first CDK4/6 inhibitor to do so in early breast cancer.
A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Ramiven (Abemaciclib) tablets in all three strengths — 50mg, 100mg, and 150mg — to hospitals, oncology centres, breast cancer clinics, and pharmacies across India. Manufactured by Eli Lilly and Company, Ramiven (Abemaciclib) is an important advance in HR-positive breast cancer treatment — addressing both metastatic disease and, uniquely among CDK4/6 inhibitors, high-risk early breast cancer.
Important — Two Different Ramiven Products at A.K. Pharma
A.K. Pharma supplies two distinct medicines under the Ramiven® brand name manufactured by Eli Lilly:
Please confirm the medicine name and form when requesting a quote to ensure the correct product is supplied.
What is Ramiven (Abemaciclib)?
Ramiven (Abemaciclib) contains Abemaciclib — a potent, selective CDK4/6 inhibitor with important pharmacological distinctions from other CDK4/6 inhibitors:
CDK4 vs CDK6 Selectivity: Abemaciclib has greater relative potency against CDK4 compared to CDK6 — with approximately 14-fold selectivity for CDK4 over CDK6 in enzymatic assays. CDK4 is considered the more important driver of Rb phosphorylation and cell cycle progression in HR-positive breast cancer — Abemaciclib’s CDK4 selectivity may contribute to its distinct pharmacological profile including continuous dosing tolerability and single-agent activity.
Continuous Twice-Daily Dosing: Unlike Palbociclib and Ribociclib which use a 3-weeks-on/1-week-off schedule, Abemaciclib is dosed continuously twice daily without a scheduled rest week. This continuous dosing maintains persistent CDK4/6 inhibition — preventing tumour cells from progressing through the cell cycle during any treatment break — and is made possible by Abemaciclib’s more selective CDK4/6 profile which results in a more manageable haematological toxicity profile than would be expected with continuous dosing of less selective CDK4/6 inhibitors.
Single-Agent Activity: Abemaciclib is the only CDK4/6 inhibitor with demonstrated single-agent anti-tumour activity in HR-positive breast cancer — reflected in its monotherapy approval. The MONARCH 1 trial demonstrated a 19.7% ORR with Abemaciclib monotherapy in heavily pre-treated HR-positive HER2-negative metastatic breast cancer — meaningful activity not observed with the other CDK4/6 inhibitors as monotherapy.
Blood-Brain Barrier Penetration: Preclinical and clinical data suggest Abemaciclib has better CNS penetration than Palbociclib and Ribociclib — with emerging evidence of activity in brain metastases from HR-positive breast cancer — an area of significant unmet need.
Full prescribing information is available at the FDA label for Abemaciclib.
Clinical Studies and Evidence
MONARCH 2 Trial (Abemaciclib + Fulvestrant in HR-Positive HER2-Negative MBC After Endocrine Therapy) Published in the Journal of Clinical Oncology (2017) with updated OS data published in Annals of Oncology (2021), MONARCH 2 was a Phase 3 randomised controlled trial of 669 patients with HR-positive HER2-negative metastatic breast cancer who had progressed on prior endocrine therapy — comparing Abemaciclib 150mg twice daily + Fulvestrant (Faslodex) vs placebo + Fulvestrant. Key results at updated OS analysis:
MONARCH 3 Trial (Abemaciclib + Aromatase Inhibitor in First-Line HR-Positive HER2-Negative MBC) Published in the Journal of Clinical Oncology (2017) with updated OS data published in Annals of Oncology (2023), MONARCH 3 enrolled 493 postmenopausal women with HR-positive HER2-negative locally advanced or metastatic breast cancer who had not received prior systemic therapy for metastatic disease — comparing Abemaciclib 150mg twice daily + non-steroidal aromatase inhibitor (Anastrozole or Letrozole) vs placebo + NSAI. Key results at updated OS analysis:
monarchE Trial (Abemaciclib as Adjuvant Therapy in High-Risk Early Breast Cancer) Published in the New England Journal of Medicine (2022) with multiple updated analyses, monarchE was a Phase 3 randomised controlled trial of 5,637 patients with HR-positive HER2-negative high-risk early breast cancer (defined by node-positive disease with either ≥4 positive nodes, or 1-3 positive nodes with Grade 3 histology or tumour size ≥5cm, or Ki-67 ≥20%) after standard adjuvant chemotherapy and radiotherapy — comparing Abemaciclib 150mg twice daily + standard endocrine therapy for 2 years vs endocrine therapy alone. Key results at 4-year follow-up:
MONARCH 1 Trial (Abemaciclib Monotherapy in Heavily Pre-Treated HR-Positive HER2-Negative MBC) Published in Clinical Cancer Research (2017), MONARCH 1 enrolled 132 women with HR-positive HER2-negative metastatic breast cancer who had received prior endocrine therapy and 1-2 prior chemotherapy regimens including a taxane. Key results:
Available Strengths
Ramiven (Abemaciclib) is available in the following tablet strengths:
| Strength | Use | Indication |
|---|---|---|
| Ramiven 50mg tablets | Dose-reduced therapy | For patients requiring dose reduction due to toxicity |
| Ramiven 100mg tablets | Combination therapy | Standard dose with endocrine therapy in some patients |
| Ramiven 150mg tablets | Standard starting dose | All indications — combination and monotherapy |
Standard starting dose: 150mg orally twice daily — continuous dosing without scheduled rest week.
All three strengths are available from A.K. Pharma — important for managing dose reductions required for toxicity management.
Indications — What Ramiven (Abemaciclib) is Used For
Metastatic Breast Cancer — In Combination With Endocrine Therapy:
Metastatic Breast Cancer — Monotherapy:
Early Breast Cancer — Adjuvant Therapy (monarchE Indication):
For detailed indication information refer to MedlinePlus Abemaciclib.
Key Benefits of Ramiven (Abemaciclib)
Proven Overall Survival Benefit in Metastatic Disease MONARCH 2 demonstrates a 9.4-month median OS benefit with Abemaciclib + Fulvestrant in second-line metastatic breast cancer — the first CDK4/6 inhibitor + endocrine combination to demonstrate significant OS benefit in second-line. MONARCH 3 updated data also demonstrates significant OS improvement in first-line — establishing Abemaciclib as an OS-proven CDK4/6 inhibitor across multiple lines of metastatic breast cancer treatment.
First CDK4/6 Inhibitor Approved for Early Breast Cancer The monarchE trial established Abemaciclib as the first CDK4/6 inhibitor with proven iDFS benefit in high-risk early breast cancer — creating an entirely new adjuvant indication for CDK4/6 inhibitors and offering patients with high-risk node-positive disease a meaningful reduction in invasive recurrence risk. This is one of the most significant advances in early breast cancer treatment in recent years.
Unique Monotherapy Approval Abemaciclib is the only CDK4/6 inhibitor with a single-agent monotherapy approval — providing a treatment option for heavily pre-treated patients who have exhausted endocrine therapy and chemotherapy options. No other CDK4/6 inhibitor has demonstrated meaningful single-agent activity.
Continuous Twice-Daily Dosing — No Rest Week Continuous CDK4/6 inhibition without a scheduled rest week may prevent the tumour cell cycle recovery that could occur during treatment breaks — potentially contributing to Abemaciclib’s durable efficacy and monotherapy activity.
CDK4 Selectivity — Favourable Haematological Tolerability Greater CDK4 selectivity relative to CDK6 results in less CDK6-driven myelosuppression compared to less selective CDK4/6 inhibitors — making continuous dosing feasible and resulting in lower rates of Grade 3-4 neutropenia (26% with Abemaciclib vs >50% with Palbociclib/Ribociclib). Neutropenia-related dose holds are less frequent — maintaining continuous CDK4/6 inhibition.
CNS Penetration — Emerging Evidence in Brain Metastases Preclinical and clinical data suggest Abemaciclib penetrates the blood-brain barrier more effectively than other CDK4/6 inhibitors — with early evidence of activity in HR-positive breast cancer brain metastases, an area of significant unmet need.
All Three Strengths Available — Full Dose Management A.K. Pharma supplies all three Abemaciclib strengths (50mg, 100mg, 150mg) — enabling full dose management including dose reductions from 150mg to 100mg to 50mg as required for toxicity, without interrupting treatment.
How Ramiven (Abemaciclib) Works
Cell Cycle Dysregulation in HR-Positive Breast Cancer:
Hormone receptor-positive breast cancer cells depend on estrogen signalling for cell cycle progression. Estrogen receptor activation drives expression of cyclin D1 — which binds and activates CDK4 and CDK6. Activated CDK4/6-cyclin D1 complexes phosphorylate the retinoblastoma protein (Rb) — releasing E2F transcription factors — activating transcription of S-phase genes — driving cell cycle progression from G1 to S phase and cell proliferation.
This CDK4/6-Rb-E2F axis is the central driver of cell cycle entry in HR-positive breast cancer — making CDK4 and CDK6 critical therapeutic targets.
Abemaciclib’s Mechanism:
Step 1 — CDK4/6 Binding: Abemaciclib binds to the ATP-binding pocket of CDK4 and CDK6 — competitively inhibiting ATP binding and preventing CDK4/6 kinase activity. Abemaciclib has approximately 14-fold greater potency against CDK4 than CDK6 — with Ki values in the low nanomolar range for both.
Step 2 — Rb Hypophosphorylation: Without CDK4/6 activity, Rb cannot be phosphorylated — Rb remains in its active, hypophosphorylated state — binding and sequestering E2F transcription factors — preventing E2F-driven S-phase gene transcription.
Step 3 — G1 Cell Cycle Arrest: Without E2F activation, cells cannot progress from G1 to S phase — cancer cells arrest in G1 — DNA replication and cell division are blocked.
Step 4 — Cellular Senescence: Prolonged G1 arrest induced by Abemaciclib leads to cellular senescence — an irreversible growth arrest state associated with Senescence-Associated Secretory Phenotype (SASP) — providing a durable anti-proliferative effect beyond simple cell cycle arrest.
Step 5 — Combination Synergy With Endocrine Therapy: Abemaciclib and endocrine therapies (aromatase inhibitors, Fulvestrant) act synergistically — endocrine therapy reduces cyclin D1 levels (less CDK4/6 activation substrate) while Abemaciclib directly inhibits CDK4/6 — dual targeting of upstream (cyclin D1) and downstream (CDK4/6) components of the same pathway provides more complete blockade than either agent alone.
For detailed mechanism overview refer to ESMO Breast Cancer Guidelines and ASCO Breast Cancer Guidelines.
Abemaciclib vs Palbociclib vs Ribociclib — CDK4/6 Inhibitor Comparison
| Feature | Ramiven (Abemaciclib) | Palbace (Palbociclib) | Kryxana (Ribociclib) |
|---|---|---|---|
| CDK4/6 selectivity | CDK4 > CDK6 (~14-fold) | CDK4/6 balanced | CDK4/6 balanced |
| Dosing schedule | Continuous twice daily | 3 weeks on / 1 week off | 3 weeks on / 1 week off |
| Monotherapy approval | ✅ Yes — unique | ❌ No | ❌ No |
| Adjuvant early BC approval | ✅ Yes (monarchE) | ❌ No | ❌ No |
| Grade 3-4 neutropenia | ~26% | ~66% | ~60% |
| Diarrhoea (any grade) | ~85% | ~26% | ~35% |
| OS benefit in metastatic | ✅ Yes (MONARCH 2, 3) | Not demonstrated | ✅ Yes (MONALEESA-2, 3, 7) |
| Premenopausal OS benefit | ✅ Yes | Not demonstrated | ✅ Yes (MONALEESA-7) |
| CNS penetration | Better | Limited | Limited |
| Available at A.K. Pharma | Request Quote | Request Quote | Request Quote |
Dosage and Administration
Metastatic Breast Cancer — Combination with Endocrine Therapy:
Metastatic Breast Cancer — Monotherapy:
Early Breast Cancer — Adjuvant (monarchE):
Administration:
Dose Reduction Schedule (for toxicity):
Monitoring:
Full dosing guidelines available at Drugs.com Abemaciclib Dosage.
Who Should Use Ramiven (Abemaciclib)
Metastatic Breast Cancer:
Early Breast Cancer (High-Risk):
Ramiven (Abemaciclib) is prescribed by medical oncologists and breast cancer specialists. A.K. Pharma supplies all three strengths to hospitals, oncology centres, breast cancer clinics, and pharmacies across Delhi and India.
Possible Side Effects
The most common side effects of Abemaciclib reflect its distinct pharmacological profile compared to other CDK4/6 inhibitors — higher rates of gastrointestinal effects but lower rates of severe neutropenia:
Common side effects include diarrhoea (85% — the most frequently reported side effect), neutropenia (41%), fatigue (40%), nausea (38%), infections (31%), anaemia (29%), decreased appetite (27%), vomiting (26%), abdominal pain (22%), and alopecia (27% in adjuvant monarchE).
Diarrhoea — Most Important Early Management Priority: Diarrhoea occurs in approximately 85% of patients — Grade 3 diarrhoea in approximately 13%. Early, proactive loperamide use at the first sign of loose stools is critical — patient education before starting treatment is essential. The majority of diarrhoea events occur early (first month) and improve with loperamide and dose management. Most patients who receive early loperamide management do not require dose reduction.
Serious side effects include:
Neutropenia: Grade 3-4 neutropenia in approximately 26% — significantly lower than Palbociclib/Ribociclib. Monitor CBC per schedule. Dose delay and reduction for Grade ≥3 neutropenia.
Hepatotoxicity: ALT/AST elevation occurs in approximately 6-8% Grade 3. Monthly LFT monitoring for first 4 months — then as clinically indicated.
Interstitial Lung Disease/Pneumonitis: Rare but serious — occurring in approximately 3.3% of patients. Monitor for new respiratory symptoms — withhold for suspected ILD pending evaluation; permanently discontinue for confirmed Grade 3-4 ILD.
Venous Thromboembolism: DVT and PE reported — particularly in the adjuvant monarchE population. Monitor for signs of VTE throughout treatment.
Embryo-Foetal Toxicity: Abemaciclib can cause foetal harm. Effective contraception required during treatment and for 3 weeks after last dose.
Full side effect information available at FDA Abemaciclib Safety Information.
Precautions
Storage and Handling
As a responsible medicine distributor in Delhi, A.K. Pharma stores all medicines including Ramiven (Abemaciclib) under manufacturer-recommended conditions ensuring product integrity for every supply.
Manufacturer Information
Ramiven (Abemaciclib) is manufactured by Eli Lilly and Company, a global pharmaceutical company with a major oncology portfolio. Abemaciclib received FDA approval in September 2017 for HR-positive HER2-negative metastatic breast cancer — with subsequent approvals for the adjuvant early breast cancer indication (monarchE) in 2021. A.K. Pharma supplies only genuine Ramiven (Abemaciclib) sourced from authorized Eli Lilly distributors.
Related Breast Cancer Medicines Available at A.K. Pharma
Frequently Asked Questions
Q. What is Ramiven (Abemaciclib) used for? Ramiven (Abemaciclib) is used to treat HR-positive HER2-negative breast cancer — in combination with endocrine therapy for advanced or metastatic disease and as monotherapy for heavily pre-treated metastatic breast cancer. It is also approved for adjuvant treatment of high-risk HR-positive HER2-negative early breast cancer in combination with endocrine therapy. More information available at MedlinePlus.
Q. What is the generic name of Ramiven tablets? The generic name of Ramiven tablets is Abemaciclib. It is a selective CDK4/6 inhibitor manufactured by Eli Lilly — same manufacturer as Ramiven injection (Ramucirumab). Please specify whether you require Ramiven tablets (Abemaciclib) or Ramiven injection (Ramucirumab) when contacting A.K. Pharma.
Q. How is Abemaciclib different from Palbociclib and Ribociclib? Key differences: Abemaciclib uses continuous twice-daily dosing (no rest week) vs 3-weeks-on/1-week-off for Palbociclib and Ribociclib. Abemaciclib is the only CDK4/6 inhibitor approved as monotherapy. Abemaciclib is the only CDK4/6 inhibitor approved for early breast cancer adjuvant treatment (monarchE). Abemaciclib has lower rates of severe neutropenia but higher rates of diarrhoea compared to the other CDK4/6 inhibitors.
Q. Is Abemaciclib approved for early breast cancer? Yes — Abemaciclib (Ramiven) is the only CDK4/6 inhibitor approved for adjuvant treatment of high-risk HR-positive HER2-negative node-positive early breast cancer. The monarchE trial demonstrated significant improvement in invasive disease-free survival with 2 years of Abemaciclib + endocrine therapy in patients with ≥4 positive nodes or 1-3 positive nodes with Grade 3 histology, tumour size ≥5cm, or Ki-67 ≥20%.
Q. What are the three strengths of Abemaciclib and when is each used? 150mg twice daily is the standard starting dose for both combination therapy and adjuvant use. 100mg twice daily is the first dose reduction level for toxicity management. 50mg twice daily is the second dose reduction level. All three strengths are available from A.K. Pharma — ensuring complete dose management flexibility without needing to source from multiple suppliers.
Q. How should diarrhoea from Abemaciclib be managed? Diarrhoea is the most common side effect — occurring in approximately 85% of patients. It is managed by starting loperamide at the first sign of loose stools — 4mg initially then 2mg after each loose stool (maximum 16mg/day). Most diarrhoea with early loperamide use does not require dose reduction. Grade 3 diarrhoea (3-4 stools above baseline per day) requires treatment withholding and dose reduction. Patient education before starting treatment is essential.
Q. Is Ramiven (Abemaciclib) the same as Verzenio? Abemaciclib is the active ingredient in both Verzenio (the originator brand name outside India) and Ramiven (the Lilly brand name used in India). Both contain the same Abemaciclib molecule manufactured by Eli Lilly.
Q. Is Ramiven (Abemaciclib) available in India? Yes. Ramiven (Abemaciclib) tablets in 50mg, 100mg, and 150mg strengths can be supplied to hospitals, oncology centres, and pharmacies across India. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.
Q. What is the price of Abemaciclib in India? Ramiven (Abemaciclib) price in India varies by strength and pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Ramiven (Abemaciclib) from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827. Please specify Ramiven tablets (Abemaciclib) when ordering to distinguish from Ramiven injection (Ramucirumab).
Q. Does A.K. Pharma supply Ramiven (Abemaciclib) in bulk? Yes. A.K. Pharma supplies Ramiven (Abemaciclib) in all three strengths in bulk to oncology centres, breast cancer clinics, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.
Why Order Ramiven (Abemaciclib) from A.K. Pharma?
Contact A.K. Pharma for Ramiven (Abemaciclib) Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in