ETCAMAH camizestrant 75 mg Tablet, Film Coated, 28-count
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UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
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UNII 1K09F3G675
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UNII XM0M87F357
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 532B59J990
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A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 059QF0KO0R
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| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Etcamah 75 mgthis 00310-0075-01 | AstraZeneca | 28 tablets | — | — | FDA listed | — |
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| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00310-0075-01 You're viewing this | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) | 2026-09-04 | Active |
| 00310-0075-95 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-95) | 2026-09-04 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| FDA label (SPL via DailyMed) | ✓ Available |
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| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ARRHYTHMIA RISK WITH CONCOMITANT USE OF QTc INTERVAL PROLONGING DRUGS ETCAMAH in combination with ribociclib, a QTc interval prolonging drug and a strong CYP3A inhibitor, or in combination with other QTc interval prolonging drugs, can increase the risk of Torsades de Pointes, other ventricular arrhythmias, and sudden death ( 5.1 , 5.2 , 7.1 ). Avoid concomitant use of ETCAMAH with products (other than ribociclib) known to prolong the QTc interval and/or have a known risk of Torsades de Pointes. If concomitant use with other products cannot be avoided, monitor the QTc interval more frequently ( 5.1 , 7.3 ).
Obtain ECG prior to initiation and monitor heart rate and QTc interval during treatment. Assess and correct electrolyte abnormalities prior to initiation and during treatment. Withhold ETCAMAH until resolution of QTc interval prolongation and resume or permanently discontinue ETCAMAH based on severity.
( 2.2 , 2.4 ) WARNING: ARRHYTHMIA RISK WITH CONCOMITANT USE OF QTc INTERVAL PROLONGING DRUGS See full prescribing information for complete boxed warning. • ETCAMAH in combination with ribociclib, a QTc interval prolonging drug and a strong CYP3A inhibitor, or in combination with other QTc interval prolonging drugs, can increase the risk of Torsades de Pointes, other ventricular arrhythmias, and sudden death ( 5.1 , 5.2 , 7.1 ). • Avoid concomitant use of ETCAMAH with products (other than ribociclib) known to prolong the QTc interval and/or have a known risk of Torsades de Pointes.
If concomitant use with other products cannot be avoided, monitor the QTc interval more frequently ( 5.1 , 7.3 ). • Obtain ECG prior to initiation and monitor heart rate and QTc interval during treatment. Assess and correct electrolyte abnormalities prior to initiation and during treatment. Withhold ETCAMAH until resolution of QTc interval prolongation and resume or permanently discontinue ETCAMAH based on severity ( 2.2 , 2.4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies ( 14 )] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ETCAMAH is an estrogen receptor antagonist indicated: • in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA authorized test.
( 1 , 2.1 ) This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Select patients for treatment with ETCAMAH based on the detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy. ( 2.1 ) • Recommended Dosage: 75 mg orally once daily with or without food. ( 2.3 ) • See Full Prescribing Information for dosage modifications for adverse reactions ( 2.4 ). • Recommended dosage for patients with hepatic impairment differs depending on the CDK4/6 inhibitor used in combination with ETCAMAH.
( 2.5 )
2.1Patient Selection Select patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have received at least 6 months of an aromatase inhibitor and CDK4/6 inhibitor therapy for treatment with ETCAMAH in combination with a CDK4/6 inhibitor based on the presence of an ESR1 mutation in plasma specimens, using an FDA-authorized test performed every 3 months until an ESR1 mutation has been detected [see Indications and Usage ( 1 ) and Clinical Studies ( 14 )] . Information on FDA-authorized tests for the detection of an ESR1 mutation in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics .
2.2Recommended Cardiac Evaluation Perform an electrocardiogram (ECG) prior to initiating ETCAMAH, then every week for the first 2 weeks of treatment, and periodically during treatment as clinically indicated [see Warnings and Precautions ( 5.1 )] . Monitor heart rate more frequently during the first 30 days of treatment with ETCAMAH in patients with bradycardia (resting heart rate less than 60 bpm) at baseline and those on concomitant medications known to lower heart rate (e.g., beta-blockers) [see Warnings and Precautions ( 5.2 )] .
2.3Recommended Dosage and Administration The recommended dosage of ETCAMAH is 75 mg orally once daily, with or without food, until disease progression or unacceptable toxicity [see Clinical Pharmacology ( 12.3 )] . Administer ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib). Continue the CDK4/6 inhibitor at the same dosage as when the ESR1 mutation was detected.
Refer to the Prescribing Information of the CDK4/6 inhibitor for additional dosing information [see Clinical Studies ( 14 )] . Take ETCAMAH at approximately the same time each day. Swallow tablets whole.
Do not cut, crush, or chew tablets prior to swallowing. Do not take broken, cracked, or otherwise not intact tablets. If a dose is missed within 6 hours, take the missed dose.
If a dose of ETCAMAH is missed for more than 6 hours, skip the dose for the day and take the next dose at the usual time. If a dose is vomited, do not take an additional dose and take the next dose at the usual time.
2.4Dosage Modifications for Adverse Reactions The recommended dosage modifications for ETCAMAH for adverse reactions are provided in Table 1. No dose reductions of ETCAMAH are recommended. Table 1.
Recommended Dosage Modifications for ETCAMAH Adverse Reaction Severity Severity as defined by NCI CTCAE version 5.0. ETCAMAH Dosage Modifications QTc Interval Prolongation [see Warnings and Precautions ( 5.1 )] QTc > 500 msec or QTc > 480 msec and prolongation from baseline > 60 msec Withhold ETCAMAH. If other contributing causes are identified, then treat or correct the contributing causes.
Resume ETCAMAH when QTc returns to < 480 msec. Re-assess ECGs weekly for the first 2 weeks of treatment, and periodically during treatment as clinically indicated. Permanently discontinue ETCAMAH if QTc interval prolongation is either > 500 msec or > 60 msec change from baseline AND associated with any of the following: Torsades de Pointes, polymorphic ventricular tachycardia, syncope, or signs/symptoms of serious arrhythmia.
Bradycardia Bradycardia includes bradycardia and sinus bradycardia. [see Warnings and Precautions ( 5.2 )] Symptomatic, Grade 2 or above Withhold ETCAMAH until symptoms resolve. Obtain ECG to evaluate etiology of symptomatic bradycardia. If a contributing concomitant medication is identified, modify…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 75 mg tablets: beige, round, bi-convex, film-coated tablets debossed with ‘CM’ above ‘75’ on one side and plain on the reverse. Tablets: 75 mg. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Bradycardia : Monitor heart rate more frequently during the first 30 days. Avoid concomitant use of ETCAMAH with other products known to cause bradycardia. Withhold or permanently discontinue ETCAMAH based on severity. ( 2.2 , 2.4 , 5.2 , 7.4 ) • Embryo-Fetal Toxicity : ETCAMAH can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 )
5.1QTc Interval Prolongation ETCAMAH in combination with a CDK4/6 inhibitor is associated with QTc interval prolongation [see Clinical Pharmacology ( 12.2 )] . When ETCAMAH is used in combination with ribociclib, a CDK4/6 inhibitor that causes QTc interval prolongation and is a strong CYP3A inhibitor, there is potential for an increased risk of Torsades de Pointes, other ventricular arrhythmias, and sudden death. One case of Torsades de Pointes was observed in a dose-finding trial when ETCAMAH was used with ribociclib [see Drug Interactions ( 7.1 , 7.3 ) and Clinical Pharmacology ( 12.2 )] .
In SERENA 6, QTc interval prolongation occurred in 2.6% of patients treated with ETCAMAH in combination with a CDK4/6 inhibitor. QTc interval prolongation led to dose interruption of ETCAMAH in 0.6% of patients. ETCAMAH also causes bradycardia, which increases the risk of QTc interval prolongation. [see Warnings and Precautions ( 5.2 )] .
Perform an ECG prior to initiating ETCAMAH, then every week for the first 2 weeks of treatment, and periodically during treatment as clinically indicated [see Dosage and Administration ( 2.2 )] . Obtain serum electrolytes at baseline and during treatment as clinically indicated, and correct electrolyte abnormalities. Avoid concomitant use of ETCAMAH in combination with a CDK4/6 inhibitor with products that can cause QTc interval prolongation, are strong CYP3A inhibitors, and/or drugs known to lower heart rate [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.1 , 7.3 , 7.4 )] .
Withhold or permanently discontinue ETCAMAH based on severity [see Dosage and Administration ( 2.4 )].
5.2Bradycardia ETCAMAH causes a decrease in heart rate. Bradycardia increases the risk for life-threatening arrhythmias and sudden death when concomitant QTc interval prolongation is present, such as when ETCAMAH is used in combination with ribociclib, both a QTc interval prolonging product and a strong CYP3A inhibitor [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 , 7.3 )] . In SERENA-6, bradycardia adverse events occurred in 8% of patients treated with ETCAMAH.
The mean heart rate decrease from baseline was approximately 13 beats per minute (bpm) with ETCAMAH with the maximum decrease observed on Day 15. The median time to onset of adverse reaction was 17 days (range 13 to 283) after starting ETCAMAH. Bradycardia led to dose interruption of ETCAMAH in 3.9% of patients.
The safety of ETCAMAH has not been established in patients with a baseline resting heart rate less than 55 bpm as these patients were excluded from SERENA-6. Monitor heart rate more frequently during the first 30 days of treatment with ETCAMAH in patients with bradycardia (heart rate less than 60 bpm) at baseline and those on concomitant medications known to lower heart rate (e.g., beta-blockers) [see Dosage and Administration ( 2.2 ), and Drug Interactions ( 7.4 )] . Withhold or permanently discontinue ETCAMAH based on severity [see Dosage and Administration ( 2.4 )] .
5.3Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, ETCAMAH can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . In animal reproduction studies, oral administration of camizestrant to rats during pregnancy resulted in adverse developmental outcomes including embryo-fetal/neonatal mortality and alterations to growth at maternal exposures below the human AUC at the recommended dose. Advise pregnant women and females of reproductive potential of the potential risk t…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (≥ 20%), including laboratory abnormalities, with ETCAMAH in combination with a CDK4/6 inhibitor were decreased neutrophils, decreased leukocytes, decreased hemoglobin, decreased lymphocytes, decreased platelets, visual disturbances, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience The following clinically significant adverse reactions are described elsewhere in the labeling: • QTc interval prolongation [see Warnings and Precautions ( 5.1 )] • Bradycardia [see Warnings and Precautions ( 5.2 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer The safety of ETCAMAH was evaluated in 155 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with detectable ESR1 mutation without disease progression during first line treatment with an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor in SERENA-6 [see Clinical Studies ( 14 )] .
Patients received ETCAMAH 75 mg orally once daily in combination with a CDK4/6 inhibitor (N = 157) or AI in combination with a CDK4/6 inhibitor (N = 158). The median duration of exposure to ETCAMAH in combination with a CDK4/6 inhibitor was 10.1 months. Serious adverse reactions occurred in 10% of patients who received ETCAMAH in combination with a CDK4/6 inhibitor.
Serious adverse reactions in > 1% of patients included urinary tract infection, pneumonia, and osteonecrosis of jaw (1.3% each). Fatal adverse reactions occurred in 1.3% of patients who received ETCAMAH in combination with a CDK4/6 inhibitor, including acute respiratory distress syndrome and sudden death (0.6% each). Permanent discontinuation of ETCAMAH due to adverse reactions occurred in 1.3% of patients.
Adverse reactions that resulted in permanent discontinuation of ETCAMAH included gastroesophageal reflux disease, cholestasis and hepatic cytolysis (0.6% each). Dosage interruption of ETCAMAH due to adverse reactions occurred in 22% of patients. Adverse reactions which required dosage interruption of ETCAMAH in ≥ 2% of patients included bradycardia (3.9%) and visual disturbances (2.6%).
The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, decreased leukocytes, decreased hemoglobin, decreased lymphocytes, decreased platelets, visual disturbances, and fatigue. Tables 2 and 3 summarize the adverse reactions and laboratory abnormalities, respectively, in SERENA-6. Table 2.
Adverse Reactions in ≥ 10% (All Grades) of Patients with HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer Who Received ETCAMAH in SERENA-6 Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse Reaction ETCAMAH with a CDK4/6 Inhibitor N = 155 Aromatase Inhibitor with a CDK4/6 Inhibitor N = 155 All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Eye Disorders Visual disturbances Visual disturbances include: photopsia, blurred vision, visual field defect, decreased visual acuity, visual impairment, diplopia, photophobia, and visual perseveration.
34 0.6 16 0 Dry eye 12 0 7 0 General Disorders and Administration Site Conditions Fatigue Fatigue includes: fatigue and asthenia. 23 0 19
0.6 Musculoskeletal and Connective Tissue Disorders Arthralgia 16 0 17
0.6Back pain 10 0.6 10 0 Gastrointestinal Disorders Nausea 10 0 14
0.6Clinically relevant adverse reactions (< 10%) in patients who received ETCAMAH included: vitreous floaters, bradycardia, and QTc prolongation. Table 3. Select Laboratory Abnormalities ≥ 10% that Worsened…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • CYP3A Inhibitors : Monitor for increased adverse reactions to ETCAMAH with strong CYP3A inhibitors and modify the dosage as recommended. ( 7.1 ) • CYP3A Inducers : Avoid concomitant use of strong and moderate CYP3A inducers. If concomitant use with a moderate CYP3A inducer cannot be avoided, dose adjustment is needed when ETCAMAH is given in combination with abemaciclib or palbociclib.
( 2.6 , 7.1 ) • CYP2C9 and/or CYP2C19 Substrates : Avoid concomitant use of ETCAMAH with CYP2C9 substrates or CYP2C19 substrates during treatment with ETCAMAH and at least 2 weeks after the last dose of ETCAMAH, unless otherwise recommended in the Prescribing Information of the CYP2C9 substrate or CYP2C19 substrate. ( 7.2 ) • CYP3A Substrates : Refer to the Prescribing Information for CYP3A substrates where minimal increases in the concentration may lead to serious adverse reactions. ( 7.2 )
7.1Effect of Other Drugs on ETCAMAH Table 5 describes drug interactions where concomitant use of another drug affects ETCAMAH. Table 5. Drug Interactions involving ETCAMAH and Other Drug Products Strong CYP3A Inhibitors Prevention or Management • Monitor for increased adverse reactions to ETCAMAH and modify the dosage as recommended [see Dosage and Administration ( 2.4 )].
Mechanism and Clinical Effect • Camizestrant is a CYP3A substrate. Concomitant use with strong CYP3A inhibitors increases camizestrant plasma concentrations [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions related to ETCAMAH. • ETCAMAH is indicated to be used in combination with CDK4/6 inhibitors, including ribociclib, which is a strong CYP3A inhibitor and can prolong the QT interval [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.3 )] . Strong and Moderate CYP3A Inducers Prevention or Management • Avoid concomitant use of strong CYP3A inducers. • The co-administration of ETCAMAH and a moderate CYP3A inducer is allowed with caution. • The dosage recommendations for concomitant use of moderate CYP3A inducers differ depending on the CDK4/6 inhibitor used in combination with ETCAMAH. o Avoid concomitant use of moderate CYP3A inducers for patients who are receiving ETCAMAH in combination with abemaciclib or palbociclib.
If concomitant use cannot be avoided, increase the ETCAMAH dosage from 75 mg once daily to 150 mg once daily for patients who are receiving ETCAMAH in combination with abemaciclib or palbociclib [see Dosage and Administration ( 2.6 )] . After the moderate CYP3A inducer has been discontinued for at least 14 days, resume the ETCAMAH dosage used prior to initiation of the moderate CYP3A inducer. o For patients who are receiving ETCAMAH in combination with ribociclib concomitantly with a moderate CYP3A inducer, no ETCAMAH dosage modification is recommended.
Mechanism and Clinical Effect • Camizestrant is a CYP3A substrate. Concomitant use with strong or moderate CYP3A inducers decreases camizestrant plasma concentrations [see Clinical Pharmacology ( 12.3 )] which may reduce ETCAMAH effectiveness.
7.2Effect of ETCAMAH on Other Drugs Table 6 describes drug interactions where concomitant use of ETCAMAH affects another drug. Table 6. Drug Interactions involving ETCAMAH and Other Drug Products CYP2C9 Substrates or CYP2C19 Substrates Prevention or Management • Avoid concomitant use of ETCAMAH with CYP2C9 substrates or CYP2C19 substrates during treatment with ETCAMAH and at least 2 weeks after the last dose of ETCAMAH, unless otherwise recommended in the Prescribing Information of the CYP2C9 substrate or CYP2C19 substrate.
Mechanism and Clinical Effect • ETCAMAH is a strong CYP2C9 inhibitor and a strong CYP2C19 inhibitor. • ETCAMAH is predicted to increase the exposure of both CYP2C9 substrates and CYP2C19 substrates [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions related to these substrates. Certain CYP3A Substrates Prevention or Management • Refer to the Prescribing Inf…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, ETCAMAH can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on ETCAMAH use in pregnant women to inform the drug-associated risk. In animal reproduction studies, oral administration of camizestrant to rats during pregnancy resulted in adverse developmental outcomes including embryo-fetal/neonatal mortality and alterations to growth at maternal exposures below the human AUC at the recommended dose (see Data) .
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In an embryo-fetal development study with pre- and post-natal assessments, female rats received camizestrant at doses of 0.1 mg/kg from gestation Day (GD) 2 to 20, doses up to 0.091 mg/kg from GD 6 to 16, or doses of 0.075 and 0.75 mg/kg from GD 6 to lactation day (LD) 6.
Administration of 0.1 mg/kg camizestrant during GD 2 to 20 resulted in no pregnancies. Camizestrant at doses ≥ 0.075 mg/kg administered from GD 6 to LD 6 resulted in increased length of gestation, dystocia, and decreased pup survival and pup weight. At all doses, maternal exposures were below the human AUC at the recommended dose.
8.2Lactation Risk Summary There are no data on the presence of camizestrant or its metabolites in human milk, its effects on milk production, or on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ETCAMAH and for 1 week after the last dose.
8.3Females and Males of Reproductive Potential ETCAMAH can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating ETCAMAH treatment. Contraception Females Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ETCAMAH and for 4 weeks after the last dose.
Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ETCAMAH and for 1 week after the last dose. Refer to the Prescribing Information of the CDK4/6 inhibitor palbociclib, if used in combination with ETCAMAH, for contraception information. Advise patients to use effective contraception during treatment and for the longest post-treatment duration as recommended in the Prescribing Information.
Infertility Based on findings from animal studies, ETCAMAH may impair fertility in females and males of reproductive potential. Findings in female animals were reversible. The reversibility of effects on male fertility in animals is unknown [see Nonclinical Toxicology ( 13.1 )] .
8.4Pediatric Use The safety and effectiveness of ETCAMAH have not been established in pediatric patients.
8.5Geriatric Use Of the 155 patients who received ETCAMAH in SERENA-6, 62 (39%) patients were ≥ 65 years of age and 5 (3.2%) patients were ≥ 75 years of age [see Clinical Studies ( 14 )] . No overall differences in safety and effectiveness were observed between patients ≥ 65 years of age and younger patients. There are insufficient number of patients ≥ 75 years of age to assess differences in safety or effectiveness.
8.6Hepatic Impairment The recommended dosage for patients with hepatic impairment differs depending on the CDK4/6 inhibitor used in combination with ETCAMAH. Reduce the dosing frequency of ETCAMAH for patients with severe (Child-Pugh C) hepatic impairment who are receiving ETCAMAH in combination with ribociclib [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action, ETCAMAH can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on ETCAMAH use in pregnant women to inform the drug-associated risk. In animal reproduction studies, oral administration of camizestrant to rats during pregnancy resulted in adverse developmental outcomes including embryo-fetal/neonatal mortality and alterations to growth at maternal exposures below the human AUC at the recommended dose (see Data) .
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data In an embryo-fetal development study with pre- and post-natal assessments, female rats received camizestrant at doses of 0.1 mg/kg from gestation Day (GD) 2 to 20, doses up to 0.091 mg/kg from GD 6 to 16, or doses of 0.075 and 0.75 mg/kg from GD 6 to lactation day (LD) 6.
Administration of 0.1 mg/kg camizestrant during GD 2 to 20 resulted in no pregnancies. Camizestrant at doses ≥ 0.075 mg/kg administered from GD 6 to LD 6 resulted in increased length of gestation, dystocia, and decreased pup survival and pup weight. At all doses, maternal exposures were below the human AUC at the recommended dose.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ETCAMAH have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 155 patients who received ETCAMAH in SERENA-6, 62 (39%) patients were ≥ 65 years of age and 5 (3.2%) patients were ≥ 75 years of age [see Clinical Studies ( 14 )] . No overall differences in safety and effectiveness were observed between patients ≥ 65 years of age and younger patients. There are insufficient number of patients ≥ 75 years of age to assess differences in safety or effectiveness.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Camizestrant is an estrogen receptor (ER) antagonist. In vitro, camizestrant binds to the ligand binding domain of ERα, antagonizing the activity of ERα encoded by both wild-type ESR1 and mutated ESR1 and inducing proteasome-dependent degradation of ERα, without agonizing ERα. Camizestrant demonstrated anti-tumor activity in ER-positive cell lines, in vitro, and patient derived xenograft (PDX) models, in vivo, including those with wild-type or mutated ESR1 genes.
Treatment with camizestrant and CDK4/6 inhibitors (abemaciclib, palbociclib, or ribociclib) demonstrated greater anti-tumor activity than single agent treatment in ER-positive cell lines and PDX models.
12.2Pharmacodynamics Exposure-Response Relationships The exposure-response relationships for efficacy of camizestrant in combination with CDK4/6 inhibitors (abemaciclib, palbociclib, and ribociclib) have not been fully characterized. Higher exposure to camizestrant was associated with increased incidence of bradycardia and visual disturbance over the dose range of 25 mg (0.3 times the recommended dose) to 450 mg (6 times the recommended dose). Cardiac Electrophysiology There is insufficient information to fully characterize the effect size of camizestrant on the QTc interval [see Warnings and Precautions ( 5.1 )] .
12.3Pharmacokinetics Camizestrant pharmacokinetics were observed at steady state in patients with breast cancer at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. Camizestrant total systemic exposure (AUC) is 1,115 ng·h/mL (40.8%) and maximum concentration (C max ) is 73.6 ng/mL (40.2%). Camizestrant steady-state AUC and C max increase by approximately 2-fold when administered in combination with ribociclib (see Drug Interaction Studies) .
Camizestrant AUC and C max increase in a greater than dose proportional manner over the dosage range of 25 mg to 450 mg (0.3 to 6 times the approved recommended dosage) once daily. Camizestrant steady state is reached by Day 5. Accumulation was observed after multiple dosing with an accumulation ratio of 1.4 for C max and 1.8 for AUC.
Absorption Camizestrant absolute oral bioavailability is 43%. Camizestrant median time to maximum concentration (T max ) is 3 to 4 hours. Effect of Food No clinically significant differences in camizestrant pharmacokinetics were observed following administration of a high-fat meal (951 calories, 58% fat) in healthy postmenopausal women.
Distribution Camizestrant apparent volume of distribution is 1,888 L (29.3%). Camizestrant plasma protein binding is 0.75 and is not concentration-dependent in vitro. The blood-to-plasma concentration ratio is 0.99.
Elimination Camizestrant terminal half-life is approximately 23 hours with an apparent clearance of 69 L/h (40.6%). Metabolism Camizestrant is primarily metabolized by CYP3A and UGT1A4. Excretion Following a single oral 75 mg dose of radiolabeled camizestrant to healthy subjects, 65% of the total radioactivity was recovered in feces (14.5% unchanged) and 17% in urine (4.8% unchanged).
Specific Populations No clinically significant differences in the pharmacokinetics of camizestrant were observed based on age (29 – 89 years), body weight (34 – 150 kg), race (86% White, 9% Asian, and 1.3% Black), and creatinine clearance (CLcr) 30 mL/min to < 90 mL/min (calculated using the modified Cockcroft-Gault equation). The effect of CLcr 15 to < 30 mL/min and end-stage renal disease (CLcr < 15 mL/min) on camizestrant pharmacokinetics is unknown. Patients with Hepatic Impairment Camizestrant C max and AUC increased in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment compared to patients with normal hepatic function following a single 75 mg dose.
Camizestrant steady state C max and AUC are predicted to increase in patients with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment compared to pati…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Camizestrant is an estrogen receptor (ER) antagonist. In vitro, camizestrant binds to the ligand binding domain of ERα, antagonizing the activity of ERα encoded by both wild-type ESR1 and mutated ESR1 and inducing proteasome-dependent degradation of ERα, without agonizing ERα. Camizestrant demonstrated anti-tumor activity in ER-positive cell lines, in vitro, and patient derived xenograft (PDX) models, in vivo, including those with wild-type or mutated ESR1 genes.
Treatment with camizestrant and CDK4/6 inhibitors (abemaciclib, palbociclib, or ribociclib) demonstrated greater anti-tumor activity than single agent treatment in ER-positive cell lines and PDX models.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Package Size Contents NDC Number 28-count bottle Bottle containing 28 tablets with desiccant 75 mg tablets: beige, round, bi-convex film-coated tablets debossed with ‘CM’ above ‘75’ on one side and plain on the reverse 0310-0075-01 Storage and Handling Store ETCAMAH at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense ETCAMAH tablets in the original bottle with desiccant to protect from moisture.
Alternatively, dispense ETCAMAH tablets in a USP equivalent tight container and discard after 30 days if stored without desiccant.
📋 Description ▾
11 DESCRIPTION ETCAMAH tablets contain camizestrant, an estrogen receptor antagonist for oral use. The chemical name is N -[1-(3-fluoropropyl)-3-azetidinyl]-6-[(6 S ,8R)-8-methyl-7-(2,2,2-trifluoroethyl)-6,7,8,9-tetrahydro-3 H -pyrazolo[4,3- f ]isoquinolin-6-yl]-3-pyridinamine. Camizestrant is white to brown powder.
The molecular formula for camizestrant is C 24 H 28 F 4 N 6 and the molecular weight is 476.51 g/mol. The chemical structure for camizestrant is shown below: Each ETCAMAH tablet contains 75 mg camizestrant and the following inactive ingredients: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating consists of ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA approved patient labeling (Patient Information). QTc Interval Prolongation Inform patients ETCAMAH is indicated to be used in combination with a CDK4/6 inhibitor and there is potential risk of additional QTc interval prolongation when combined with ribociclib and/or products that can cause QTc interval prolongation, which may increase the risk of Torsades de Pointes, other ventricular arrhythmias, and sudden death. Advise patients that ECG will be monitored before treatment and thereafter.
Advise patients or caregivers to seek immediate medical attention if they suspect or develop signs or symptoms associated with clinical consequences of QTc interval prolongation. Instruct patients to consult with their healthcare provider prior to taking other drugs that cause QTc interval prolongation with ETCAMAH [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 , 7.3 )] . Bradycardia Inform patients ETCAMAH causes decrease in heart rate.
Advise patients that heart rate will be monitored more frequently during the first 30 days of treatment with ETCAMAH in patients with bradycardia (heart rate less than 60 bpm) at baseline and those on concomitant medications known to lower heart rate. Advise patients to report any symptoms of bradycardia and to inform their healthcare provider about the use of any heart and blood pressure medications [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.4 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective non hormonal contraception during treatment with ETCAMAH and for 4 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ETCAMAH and for 1 week after the last dose [see Use in Specific Populations ( 8.3 )] .
For male patients with female partners of reproductive potential, refer to the Prescribing Information of the CDK4/6 inhibitor palbociclib if used in combination with ETCAMAH for contraception information. Advise patients to use effective contraception during treatment and for the longest post-treatment duration as recommended in the Prescribing Information. Lactation Advise women not to breastfeed during treatment with ETCAMAH and for 1 week after the last dose [see Use in Specific Populations ( 8.2 )] .
Infertility Advise males and females of reproductive potential that ETCAMAH may impair fertility [see Use in Specific Populations ( 8.3 )] . Drug Interactions Advise patients to inform their healthcare provider(s) of all the concomitant medications that will be taken with ETCAMAH, including prescription medicines, over-the-counter medicines, vitamins, and herbal products [see Drug Interactions ( 7 )] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 ETCAMAH is a registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2026
💬 Patient Medication Information ▾
Patient Information PATIENT INFORMATION ETCAMAH® (et kam’ ah) (camizestrant) tablets, for oral use What is the most important information I should know about ETCAMAH? ETCAMAH can cause serious side effects including: • Changes in electrical activity of your heart (QTc interval prolongation). Taking ETCAMAH in combination with ribociclib or other QTc interval prolonging drugs may cause life-threatening heart rhythm problems and may lead to death.
Before starting and during treatment with ETCAMAH, your healthcare provider will do an electrocardiogram (ECG) to check the electrical activity of your heart and do blood tests to check the blood levels of your body salts (electrolytes). Your healthcare provider will treat abnormal electrolyte levels. • Slow heart rate (bradycardia). Your healthcare provider will check your heart rate frequently during the first 30 days of treatment with ETCAMAH if you have bradycardia (heart rate less than 60 beats per minute) before starting treatment and if you take medicines that lower heart rate.
Get medical help right away if you get the following signs or symptoms of QTc interval prolongation and bradycardia including: o dizziness o lightheadedness o fainting o feeling that your heart is pounding or racing (palpitations) o shortness of breath o chest pain Your healthcare provider may delay treatment or completely stop treatment with ETCAMAH if you have severe side effects. See “What are the possible side effects of ETCAMAH?” for more information about side effects. What is ETCAMAH?
ETCAMAH is a prescription medicine used in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) to treat adults with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that: • has worsened or spread to other parts of the body (advanced or metastatic breast cancer), and • has an estrogen receptor-1 ( ESR1 ) mutation detected during treatment with an aromatase inhibitor and a CDK4/6 inhibitor. Your healthcare provider will perform a test to make sure that ETCAMAH is right for you.
It is not known if ETCAMAH is safe and effective in children. Before you take ETCAMAH, tell your healthcare provider if you: • have any liver-related problems. • have a slow heartbeat (bradycardia). • have heart problems including irregular heartbeats and QTc prolongation. • are pregnant or plan to become pregnant. ETCAMAH can harm your unborn baby.
Females who are able to become pregnant o Your healthcare provider will check that you are not pregnant before you start treatment with ETCAMAH. o Use effective non-hormonal birth control (contraception) during treatment with ETCAMAH and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you during this time. o Tell your healthcare provider if you become pregnant or think you may be pregnant. Males with female partners who can become pregnant o Use effective birth control during treatment with ETCAMAH and for 1 week after your last dose. • are breast-feeding or plan to breast-feed.
It is not known if ETCAMAH passes into your breast milk. Do not breast feed during treatment with ETCAMAH and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with ETCAMAH.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take any heart and blood pressure medicines. ETCAMAH may affect the way other medicines work, and other medicines may affect how ETCAMAH works.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take ETCAMAH? • Take ETCAMAH exactly as your healthcare provider tells you. • Do not change your dose or stop taking ETCAMAH without talking to your healthcare provide…