INLEXZO™ (gemcitabine intravesical system)
INLEXZO Coding & Reimbursement Hub
How to use this page
- Start here (Overview): quick orientation to INLEXZO access, coding, and reimbursement issues
- Physician Coding tab: professional coding logic for office-based insertion/removal, diagnosis coding, NDC/HCPCS reporting, and documentation tips
- Facility Coding tab: hospital outpatient and ASC charge capture, revenue code, UB-04/CMS-1450 and CMS-1500 considerations, and documentation alignment
- Right-side “Additional Resources”: access resources, prior authorization resources, and PRS quick-reference tools
What INLEXZO is
INLEXZO (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Please scroll to see full Important Safety Information for INLEXZO.
Reimbursement orientation
- Product coding: HCPCS Level II J9183 — Gemcitabine intravesical system, 225 mg
- NDC reporting: 11-digit NDC 57894-0225-01; one INLEXZO intravesical system equals 1 NDC unit
- Procedure coding: insertion may involve 51720; removal may involve 52310 when supported by the medical record
- Site of care matters: coding and payment workflows differ for physician office, hospital outpatient department, and ambulatory surgical center claims
- Payer rules vary: verify coverage, prior authorization, acquisition pathway, NDC format, revenue codes, and claim form requirements before implementation
Access workflow at a glance
- Complete benefits investigation and connect patients with J&J withMe support
- Submit prior authorization or medical exception request when required
- Acquire INLEXZO through buy-and-bill or specialty pharmacy based on payer coverage and contracting
- Submit the reimbursement claim for INLEXZO and the related procedure, then track claim status and appeals if needed
- Confirm insurance changes before follow-up appointments and subsequent treatment cycles
Transparency
- Thank you to Johnson & Johnson for supporting this hub
- PRS retains editorial control over independent coding, billing, and reimbursement interpretation
- INLEXZO-specific product information, labeling, and proprietary reimbursement materials are property of Johnson & Johnson
- This content is educational and does not guarantee coverage, payment, or payer acceptance
INLEXZO is a registered trademark of Johnson & Johnson.
This information does not provide advice or guarantee coverage or payment. Legal requirements and plan information can be updated frequently. We strongly recommend contacting the plan for more information about current coverage, restrictions, or prerequisites that may apply.
Physician Coding (INLEXZO)
Professional reporting should reflect the diagnosis, the INLEXZO product supplied/administered, the insertion/removal service performed, and payer-specific requirements for NDC, units, modifiers, and prior authorization.
Product code
- J9183 — Gemcitabine intravesical system, 225 mg
- Each 225-mg intravesical system represents 1 unit of J9183
NDC reporting
- 10-digit NDC: 57894-225-01
- 11-digit NDC: 57894-0225-01
- NDC unit of measure: UN
- NDC units: 1
- Example professional claim format: N457894022501 UN1
Procedure codes
Insertion
- 51720 — Bladder instillation of anticarcinogenic agent, including retention time
Removal
- 52310 — Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder; simple. Use only when supported by the removal service documented
NCCI note: Per current NCCI, codes 51720 and 52310 are not bundled and can be reported on the same date of service when supported by documentation; however, multiple procedure discounts will be applied.
INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Please scroll to see full Important Safety Information for INLEXZO.
Common diagnosis codes that may be relevant when supported by the record include:
- C67.0 — Malignant neoplasm of trigone of bladder
- C67.1 — Malignant neoplasm of dome of bladder
- C67.2 — Malignant neoplasm of lateral wall of bladder
- C67.3 — Malignant neoplasm of anterior wall of bladder
- C67.4 — Malignant neoplasm of posterior wall of bladder
- C67.5 — Malignant neoplasm of bladder neck
- C67.6 — Malignant neoplasm of ureteric orifice
- C67.8 — Malignant neoplasm of overlapping sites of bladder
- C67.9 — Malignant neoplasm of bladder, unspecified
- D09.0 — Carcinoma in situ of bladder
- Z85.51 — Personal history of malignant neoplasm of bladder
Practical point: Code to the highest specificity supported by the treating record and align diagnosis reporting with the approved indication and payer medical-necessity policy.
Note: C67.9 is not considered specific enough for many payers; this specificity issue should be matched across all product pages where bladder cancer ICD-10-CM codes are listed.
Documentation should support both the product and the professional work performed.
- Diagnosis: bladder cancer site, CIS status, BCG-unresponsive status, relevant prior therapy, and clinical rationale for treatment
- Product: INLEXZO name, dose/system, NDC when required by the payer, lot/serial information per practice policy, and whether the product was obtained through buy-and-bill or specialty pharmacy
- Insertion: intravesical administration/insertion details, catheter/stylet use, date of insertion, and tolerance/complications
- Removal: removal date, cystoscopy/removal details when applicable, and whether a new system was inserted on the same date
- Medical necessity: treatment rationale, prior therapy history, current disease status, and payer-required prior authorization or exception documentation
- Claim support: prior authorization number if required, NDC quantity/unit, J-code units, and any payer-specific attachments
Modifier and claim considerations
- JZ modifier: Medicare requires reporting JZ on separately payable Part B single-dose container drugs when no amount is discarded. Confirm payer instructions for INLEXZO claims
- POS 11: physician office claims generally use place of service 11 when the service is furnished in the office
- Prior authorization: many payers may require prior authorization or medical exception review; verify before treatment
Common physician-side pitfalls
- NDC mismatch: payer requires 11-digit NDC but claim reports a 10-digit format or omits the N4 qualifier
- Unit mismatch: INLEXZO uses 1 J-code unit because the J9183 code definition is assigned to the device/common drug dose for all patients
- Procedure ambiguity: insertion/removal details are not clear enough to support the procedure code billed
- Authorization gap: drug authorization obtained but procedure/site-of-care authorization not confirmed, or vice versa
- Buy-and-bill vs specialty pharmacy confusion: acquisition pathway not aligned with payer benefit determination
Transparency
- Thank you to Johnson & Johnson for supporting this hub
- PRS retains editorial control over independent coding, billing, and reimbursement interpretation
- INLEXZO-specific product information, labeling, and proprietary reimbursement materials are property of Johnson & Johnson
- This content is educational and does not guarantee coverage, payment, or payer acceptance
INLEXZO is a registered trademark of Johnson & Johnson.
This information does not provide advice or guarantee coverage or payment. Legal requirements and plan information can be updated frequently. We strongly recommend contacting the plan for more information about current coverage, restrictions, or prerequisites that may apply.
Facility Coding (INLEXZO)
Facility reporting depends on whether care occurs in the hospital outpatient department or ambulatory surgical center, whether the facility acquired the product, and whether the payer requires revenue code, NDC, HCPCS, authorization, and claim-form-specific reporting.
Product and revenue coding
- J9183 — Gemcitabine intravesical system, 225 mg
- 11-digit NDC: 57894-0225-01
- Revenue code 0636 — Pharmacy, drugs requiring detailed coding. Typically relevant for hospital outpatient drug reporting
Procedure coding
Insertion
- 51720 — Bladder instillation of anticarcinogenic agent, including retention time
Removal
- 52310 — Cystourethroscopy with simple removal from urethra or bladder, when supported by documentation
NCCI note: Per current NCCI, codes 51720 and 52310 are not bundled and can be reported on the same date of service when supported by documentation; however, multiple procedure discounts will be applied.
- Revenue code 0360 — Operating room services, general, when applicable to the facility service line and payer instructions
Claim forms
- HOPD: generally reported on CMS-1450 / UB-04 or electronic 837I
- ASC: payer and contracting rules may drive CMS-1500/837P vs institutional reporting requirements. Confirm payer instructions before go-live
INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Please scroll to see full Important Safety Information for INLEXZO.
Facility diagnosis reporting should match the reason for the encounter and the treating record. Common codes include:
- C67.0 — Malignant neoplasm of trigone of bladder
- C67.1 — Malignant neoplasm of dome of bladder
- C67.2 — Malignant neoplasm of lateral wall of bladder
- C67.3 — Malignant neoplasm of anterior wall of bladder
- C67.4 — Malignant neoplasm of posterior wall of bladder
- C67.5 — Malignant neoplasm of bladder neck
- C67.6 — Malignant neoplasm of ureteric orifice
- C67.8 — Malignant neoplasm of overlapping sites of bladder
- C67.9 — Malignant neoplasm of bladder, unspecified
- D09.0 — Carcinoma in situ of bladder
- Z85.51 — Personal history of malignant neoplasm of bladder
Practical point: Code to the highest specificity supported by the treating record and align diagnosis reporting with the approved indication and payer medical-necessity policy.
Note: C67.9 is not considered specific enough for many payers; this specificity issue should be matched across all product pages where bladder cancer ICD-10-CM codes are listed.
Facility reimbursement depends on clean alignment among the physician note, nursing record, supply log, pharmacy record, chargemaster, and claim.
- Product capture: INLEXZO system, NDC, quantity, acquisition pathway, pharmacy/supply documentation, and charge capture
- Procedure capture: insertion/removal services, cystoscopy if performed, same-day removal/new insertion if applicable, and operating/procedure room resources
- Authorization support: payer authorization number, coverage determination, benefit category, and exception/appeal documentation if needed
- Revenue integrity: line-item charges should match documented drug, procedure, and supply use
- Record alignment: physician order, operative/procedure note, medication administration record, nursing notes, and claim lines should tell the same story
Acquisition and site-of-care issues
- Dual procurement pathways: determine whether payer coverage supports buy-and-bill or specialty pharmacy before ordering
- Benefits investigation: use J&J withMe or payer-specific workflows to verify coverage, prior authorization, patient cost share, and acquisition pathway
- Appeals readiness: maintain denial reason, original claim, prior authorization record, medical necessity support, and product information for appeal submissions
Common facility-side pitfalls
- Missing revenue code: HOPD drug line lacks detailed coding support when the payer expects it
- Product/procedure split: product is documented, but the procedure service line is incomplete or not supported
- Specialty pharmacy confusion: facility bills for product it did not acquire or payer expects alternate billing pathway
- NDC formatting issues: electronic claim rejects because NDC format, qualifier, unit of measure, or quantity is not payer compliant
Transparency
- Thank you to Johnson & Johnson for supporting this hub
- PRS retains editorial control over independent coding, billing, and reimbursement interpretation
- INLEXZO-specific product information, labeling, and proprietary reimbursement materials are property of Johnson & Johnson
- This content is educational and does not guarantee coverage, payment, or payer acceptance
INLEXZO is a registered trademark of Johnson & Johnson.
This information does not provide advice or guarantee coverage or payment. Legal requirements and plan information can be updated frequently. We strongly recommend contacting the plan for more information about current coverage, restrictions, or prerequisites that may apply.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.
Magnetic Resonance Imaging (MRI) Safety
INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions.
Embryo-Fetal Toxicity
Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™.
ADVERSE REACTIONS
Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder.
The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk.
Please see Embryo-Fetal Toxicity for risk information related to pregnancy.
Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™.
Females and Males of Reproductive Potential
Pregnancy Testing - Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™.
Contraception - Please see Embryo-Fetal Toxicity for information regarding contraception.
Infertility (Males) - Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible.
Geriatric Use
Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.
Please read full Prescribing Information and Instructions for Use for INLEXZO™.
cp-520096v1
INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.
Magnetic Resonance Imaging (MRI) Safety
INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions.
Embryo-Fetal Toxicity
Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™.
ADVERSE REACTIONS
Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder.
The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk.
Please see Embryo-Fetal Toxicity for risk information related to pregnancy.
Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™.
Females and Males of Reproductive Potential
Pregnancy Testing - Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™.
Contraception - Please see Embryo-Fetal Toxicity for information regarding contraception.
Infertility (Males) - Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible.
Geriatric Use
Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.
Please read full Prescribing Information and Instructions for Use for INLEXZO™.
cp-520096v1
INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
INDICATION
INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.
Magnetic Resonance Imaging (MRI) Safety
INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions.
Embryo-Fetal Toxicity
Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™.
ADVERSE REACTIONS
Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder.
The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk.
Please see Embryo-Fetal Toxicity for risk information related to pregnancy.
Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™.
Females and Males of Reproductive Potential
Pregnancy Testing - Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™.
Contraception - Please see Embryo-Fetal Toxicity for information regarding contraception.
Infertility (Males) - Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible.
Geriatric Use
Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.
Please read full Prescribing Information and Instructions for Use for INLEXZO™.
cp-520096v1
