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Cladribine 10 mg Tablet, 4-count — NDC 62049-0286-04 package photo

Cladribine 10 mg Tablet, 4-count

by Genvion Corporation · 4 TABLET in 1 CARTON (62049-286-04)
NDC 62049-0286-04
🏷️ FDA NDC (as labeled) 62049-286-04 billing pads the product segment with a zero
This package
Contains4-count Pack sizes7 compare ↓
Also priced by: Part D plans $9,407.66/unit — full pricing hub ↓
Also comes in: 5 tablets 62049-0286-05 6 tablets 62049-0286-06 7 tablets 62049-0286-07 8 tablets 62049-0286-08 9 tablets 62049-0286-09 10 tablets 62049-0286-10
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62049-286-04
Product NDC 62049-286
11-digit billing NDC 62049028604
RxCUI 2122634, 2122635, 2122647, 2122649, 2122654, 2122656, 2122658, 2122660
UNII 47M74X9YT5
Application # ANDA218425
SPL Set ID f1d650a5-4205-720b-f39b-4213277b6612
Established class (EPC) Purine Antimetabolite
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-25
Route ORAL
Dosage form TABLET
Substance CLADRIBINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62049-286-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62049-0286-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Purine Antimetabolite class.

Pharmacologic class Purine Antimetabolite
Drug family (ATC) Purine analogues, Selective immunosuppressants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGenvion Corporation
Application holderAPOTEX INC
FDA applicationANDA218425 (ANDA)
Labeler code62049
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's actually both, depending on the form. The oral tablets (brand name Mavenclad) are approved to treat relapsing forms of multiple sclerosis in adults — specifically for people w...
  • What exactly is cladribine used for — is it a chemotherapy or an MS drug?
  • Not exactly like a daily pill. The oral tablets are taken in a structured course — two yearly treatment courses, and each course is split into two short cycles of daily dosing. So...
  • How do I actually take the MS tablets — do I take them every day?
📖 Read our full Cladribine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
Imprint10
Size4 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer 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.
Medicare drug plans payPart D · Q2 2026 $9,407.66 $37,630.65 / 4 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mavenclad 10 mg 44087-4000-00 EMD 10 tablets — AB FDA listed —
Cladribine 10 mg 00781-8201-37 Sandoz 9 tablets — AB FDA listed —
Cladribine 10 mgthis 62049-0286-04 Genvion 4 tablets — AB FDA listed —
Cladribine 10 mg 60505-4791-01 Apotex 10 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cladribine — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cladribine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.86M
Claims incl. refills
116
Beneficiaries
87
Spend / beneficiary
$78,907.24
Spend / claim
$59,180.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Cladribine — the ingredient across all brands.

Top reported reactions

Fatigue814
Headache681
Lymphocyte Count Decreased488
Multiple Sclerosis Relapse474
Nausea423
Pneumonia406
White Blood Cell Count Decreased363

Age at onset

Neonate30
Infant24
Child21
Adolescent18
Adult4,970
Elderly660

Reporter sex

9,555 reports
Male · 30%
Female · 69%
Unknown · 0%

Serious outcomes

Life-threatening278
Disabling121
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,056 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62049-0286-04 You're viewing this 4 TABLET in 1 CARTON (62049-286-04) 2025-11-25 Active
62049-0286-05 5 TABLET in 1 CARTON (62049-286-05) 2025-11-25 Active
62049-0286-06 6 TABLET in 1 CARTON (62049-286-06) 2025-11-25 Active
62049-0286-07 7 TABLET in 1 CARTON (62049-286-07) 2025-11-25 Active
62049-0286-08 8 TABLET in 1 CARTON (62049-286-08) 2025-11-25 Active
62049-0286-09 9 TABLET in 1 CARTON (62049-286-09) 2025-11-25 Active
62049-0286-10 10 TABLET in 1 CARTON (62049-286-10) 2025-11-25 Active

You're viewing the smallest of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 62049-0286-04?
NDC 62049-0286-04 is a 4-count package — 4 tablet in 1 carton.
What is the difference between NDC 62049-0286-04 and NDC 62049-0286-05?
Both are Cladribine 10 mg Tablet — the drug itself is identical. NDC 62049-0286-04 is the 4-count package, while NDC 62049-0286-05 is the 5 tablets package.
What NDC number is used to bill for this package of Cladribine 10 mg Tablet?
Bill NDC 62049-0286-04 — the 11-digit billing format is 62049028604. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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 ✓ Available
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 62049-286-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62049-0286-04, written without dashes as 62049028604. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62049-0286-04, the first segment (62049) is the labeler code FDA assigned to Genvion Corporation; the middle segment (0286) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genvion Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 5 tablets (62049-0286-05), 6 tablets (62049-0286-06), 7 tablets (62049-0286-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Genvion Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: MALIGNANCIES AND RISK OF TERATOGENICITY Malignancies Treatment with cladribine tablets may increase the risk of malignancy. Cladribine tablets are contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine tablets on an individual patient basis.

Follow standard cancer screening guidelines in patients treated with cladribine tablets [see Contraindications (4) and Warnings and Precautions ( 5.1 )] . Risk of Teratogenicity Cladribine tablets are contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals.

Exclude pregnancy before the start of treatment with cladribine tablets in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course. Stop cladribine tablets if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.1, 8.3)] .

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY See full prescribing information for complete boxed warning. Malignancies Cladribine tablets may increase the risk of malignancy. Cladribine tablets are contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy.

( 5.1 ) Risk of Teratogenicity Cladribine tablets are contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm. ( 5.2 )

🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE Cladribine tablets are indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of cladribine tablets is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [ see Warnings and Precautions (5) ]. Limitations of Use Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [ see Warnings and Precautions (5) ].

Cladribine tablets are purine antimetabolite indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of cladribine tablets are generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. ( 1 , 5 ) Limitations of Use Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

( 1 , 5 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Assessments are required prior to starting each cladribine treatment course. (2.1) Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles. (2.2) Cladribine tablets are a cytotoxic drug. (2.4) Separate administration from any other oral drug by at least 3 hours. (2.4)

2.1Assessments Prior to Starting Each Cladribine Treatment Course Cancer Screening Follow standard cancer screening guidelines because of the risk of malignancies [ see Boxed Warning and Warnings and Precautions (5.1) ]. Pregnancy Exclude pregnancy prior to treatment with cladribine tablets in females of reproductive potential [ see Contraindications (4) , Warnings and Precautions (5.2) , and Use in Specific Populations (8.1, 8.3) ]. Complete Blood Count (CBC) Obtain a CBC with differential including lymphocyte count [ see Dosage and Administration (2.5) and Warnings and Precautions (5.3) ].

Lymphocytes must be: within normal limits before initiating the first treatment course at least 800 cells per microliter before initiating the second treatment course If necessary, delay the second treatment course for up to 6 months to allow for recovery of lymphocytes to at least 800 cells per microliter. If this recovery takes more than 6 months, the patient should not receive further treatment with cladribine tablets. Infections [ see Warnings and Precautions (5.4) ] Exclude HIV infection.

Perform tuberculosis screening. Screen for hepatitis B and C. Evaluate for acute infection.

Consider a delay in cladribine treatment until any acute infection is fully controlled. Vaccination of patients who are seronegative for VZV is recommended prior to initiation of cladribine tablets. Vaccination of patients who are seropositive to VZV is recommended with zoster vaccine recombinant, adjuvanted.

Patients may be administered zoster vaccine recombinant, adjuvanted at any time prior to or during the year 1 or year 2 course of cladribine treatment. These patients may also be administered the vaccine if their lymphocyte counts are ≤ 500 cells per microliter. Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting cladribine tablets.

Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting cladribine tablets. Obtain a baseline (within 3 months) magnetic resonance imaging prior to the first treatment course because of the risk of progressive multifocal leukoencephalopathy (PML). Liver Injury Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to each treatment cycle and course [ see Warnings and Precautions (5.7) ].

2.2Recommended Dosage The recommended cumulative dosage of cladribine tablets is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course) (see Table 1). Each treatment course is divided into 2 treatment cycles: Administration of First Treatment Course First Course/First Cycle: start any time. First Course/Second Cycle: administer 23 to 27 days after the last dose of First Course/First Cycle.

Administration of Second Treatment Course Second Course/First Cycle: administer at least 43 weeks after the last dose of First Course/Second Cycle. Second Course/Second Cycle: administer 23 to 27 days after the last dose of Second Course/First Cycle. Table 1 Dose of Cladribine tablets per Cycle by Patient Weight in Each Treatment Course Weight Range Dose in mg (Number of 10 mg Tablets) per Cycle kg First Cycle Second Cycle 40* to less than 50 40 mg (4 tablets) 40 mg (4 tablets) 50 to less than 60 50 mg (5 tablets) 50 mg (5 tablets) 60 to less than 70 60 mg (6 tablets) 60 mg (6 tablets) 70 to less than 80 70 mg (7 tablets) 70 mg (7 tablets) 80 to less than 90 80 mg (8 tablets) 70 mg (7 tablets) 90 to less than 100 90 mg (9 tablets) 80 mg (8 tablets) 100 to l…

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Cladribine tablets are available as 10 mg tablets. The tablets are white to off white, round, biconvex tablets debossed with “10” on one side and plain on the other side. Tablets: 10 mg (3)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Cladribine tablets are contraindicated: in patients with current malignancy [ see Warnings and Precautions (5.1) ] . in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course. May cause fetal harm [ see Warnings and Precautions (5.2) and Use in Specific Populations (8.1, 8.3 )]. in patients infected with the human immunodeficiency virus (HIV) [ see Warnings and Precautions (5.4) ]. in patients with active chronic infections (e.g., hepatitis or tuberculosis) [ see Warnings and Precautions (5.4) ]. in patients with a history of hypersensitivity to cladribine [ see Warnings and Precautions (5.8) ]. in women intending to breastfeed on a cladribine treatment day and for 10 days after the last dose [ see Use in Specific Populations (8.2) ].

Patients with current malignancy. (4) Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during cladribine tablets dosing and for 6 months after the last dose in each treatment course. (4, 8.3) HIV infection.

(4) Active chronic infections (e.g., hepatitis or tuberculosis). (4) History of hypersensitivity to cladribine. (4, 5.8) Women intending to breastfeed on a cladribine treatment day and for 10 days after the last dose.

(4, 8.2)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Lymphopenia: Monitor lymphocyte counts before, during and after treatment. (5.3) Infections: Serious, including life-threatening and fatal infections, have occurred. Screen patients for active and latent infections; delay treatment until infection is fully resolved or controlled.

Vaccination of patients seronegative to varicella zoster virus (VZV) is recommended prior to treatment. Vaccination of patients seropositive to VZV with zoster vaccine recombinant, adjuvanted, is recommended prior to or during treatment. Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter.

Monitor for infections. (5.4) Hematologic toxicity: Monitor complete blood count before, during and after treatment. (5.5) Graft-versus-host-disease with blood transfusion: Irradiation of cellular blood components is recommended.

(5.6) Liver injury: Clinically significant liver injury has occurred. Obtain tests prior to treatment. Discontinue if clinically significant injury is suspected.

(5.7)

5.1Malignancies Treatment with cladribine tablets may increase the risk of malignancy. In controlled and extension clinical studies worldwide, malignancies occurred more frequently in cladribine-treated patients [10 events in 3,754 patient-years (0.27 events per 100 patient-years)], compared to placebo patients [3 events in 2,275 patient-years (0.13 events per 100 patient-years)]. Malignancy cases in cladribine patients included metastatic pancreatic carcinoma, malignant melanoma (2 cases), ovarian cancer, compared to malignancy cases in placebo patients, all of which were curable by surgical resection [basal cell carcinoma, cervical carcinoma in situ (2 cases)].

The incidence of malignancies in United States cladribine clinical study patients was higher than the rest of the world [4 events in 189 patient-years (2.21 events per 100 patient-years) compared to 0 events in United States placebo patients]; however, the United States results were based on a limited amount of patient data. After the completion of 2 treatment courses, do not administer additional cladribine treatment during the next 2 years [ see Dosage and Administration (2.2) ]. In clinical studies, patients who received additional cladribine treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy [7 events in 790 patient-years (0.91 events per 100 patient-years) calculated from the start of cladribine treatment in Year 3].

The risk of malignancy with reinitiating cladribine tablets more than 2 years after the completion of 2 treatment courses has not been studied. Cladribine tablets are contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of cladribine tablets on an individual patient basis.

Follow standard cancer screening guidelines in patients treated with cladribine tablets.

5.2Risk of Teratogenicity Cladribine tablets may cause fetal harm when administered to pregnant women. Malformations and embryolethality occurred in animals [ see Use in Specific Populations (8.1) ] . Advise women of the potential risk to a fetus during cladribine tablets dosing and for 6 months after the last dose in each treatment course.

In females of reproductive potential, pregnancy should be excluded before initiation of each treatment course of cladribine tablets and prevented by the use of effective contraception during cladribine tablets dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with cladribine tablets should discontinue treatment [ see Use in Specific Populations (8.1 , 8.3) ] . Cladribine tablets are contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception.

5.3 Lymphopenia Cladribine tablets cause a dose-dependent reduction in lympho…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions and potential risks are discussed, or discussed in greater detail, in other sections of the labeling: Malignancies [ see Warnings and Precautions (5.1) ] Risk of Teratogenicity [ see Warnings and Precautions (5.2) ] Lymphopenia [ see Warnings and Precautions (5.3)] Infections [ see Warnings and Precautions (5.4) ] Hematologic Toxicity [ see Warnings and Precautions (5.5) ] Graft-Versus-Host Disease With Blood Transfusion [ see Warnings and Precautions (5.6) ] Liver Injury [ see Warnings and Precautions (5.7) ] Hypersensitivity [ see Warnings and Precautions (5.8) ] Cardiac Failure [ see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence > 20%) are upper respiratory tract infection, headache, and lymphopenia.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical studies 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 studies of another drug and may not reflect the rates observed in practice. In the clinical trial program of cladribine in MS, 1,976 patients received cladribine for a total of 9,509 patient years. The mean time on study including follow-up was approximately 4.8 years, and approximately 24% of cladribine-treated patients had approximately 8 years of time on study including follow-up.

Of these, 923 patients aged 18 to 66 years received cladribine as monotherapy at a cumulative dose of 3.5 mg per kg. Table 2 shows adverse reactions in Study 1 [ see Clinical Studies (14) ] with an incidence of at least 5% for cladribine and higher than placebo. The most common (> 20%) adverse reactions reported in Study 1 are upper respiratory tract infection, headache, and lymphopenia.

Table 2 Adverse Reactions in Study 1 with an Incidence of at Least 5% for Cladribine tablets and Higher than Placebo Cladribine (N=440) % Placebo (N=435) % Upper respiratory tract infection 38 32 Headache 25 19 Lymphopenia 24 2 Nausea 10 9 Back pain 8 6 Arthralgia and arthritis 7 5 Insomnia 6 4 Bronchitis 5 3 Hypertension 5 3 Fever 5 3 Depression 5 3 Hypersensitivity In clinical studies, 11% of cladribine patients had hypersensitivity adverse reactions, compared to 7% of placebo patients [see Warnings and Precautions ( 5.8 )].

Alopecia Alopecia occurred in 3% of cladribine-treated patients compared to 1% of placebo patients. Myelodysplastic Syndrome Cases of myelodysplastic syndrome have been reported in patients that had received parenteral cladribine at a higher dosage than that approved for cladribine. These cases occurred several years after treatment.

Herpes Meningoencephalitis Fatal herpes meningoencephalitis occurred in one cladribine-treated patient, at a higher dosage and longer duration of therapy than the approved cladribine dosage and in combination with interferon beta-1a treatment. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) SJS and TEN are identified risks of parenteral cladribine for the treatment of oncologic indications. Seizures In clinical studies, serious events of seizure occurred in 0.3% of cladribine-treated patients compared to 0 placebo patients.

Serious events included generalized tonic-clonic seizures and status epilepticus. It is unknown whether these events were related to the effects of multiple sclerosis alone, to cladribine, or to a combination of both.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of cladribine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and Infestations: nocardiosis, varicella zoster, histoplasmosis, cryptococcosis, and toxoplasmos…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 3 Drug Interactions with cladribine tablets

7.1Immunomodulatory, Immunosuppressive, or Myelosuppressive Drugs Clinical Impact Concomitant use of cladribine with immunomodulatory, immunosuppressive, or myelosuppressive drugs may increase the risk of adverse reactions because of the additive effects on the immune system [see Warnings and Precautions ( 5.4 )]. Prevention or Management Concomitant use with myelosuppressive or other immunosuppressive drugs is not recommended. Acute short-term therapy with corticosteroids can be administered.

In patients who have previously been treated with immunomodulatory or immunosuppressive drugs, consider potential additive effect, the mode of action, and duration of effect of the other drugs prior to initiation of cladribine.

7.2Interferon-Beta Clinical Impact Concomitant use of cladribine with interferon-beta did not change the exposure of cladribine to a clinically significant effect; however, lymphopenia risk may be increased [ see Warnings and Precautions (5.3) ]. Prevention or Management Concomitant use is not recommended.

7.3Hematotoxic Drugs Clinical Impact Concomitant use of cladribine with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects [ see Warnings and Precautions (5.5) ]. Prevention or Management Monitor hematological parameters.

7.4Antiviral and Antiretroviral Drugs Clinical Impact Compounds that require intracellular phosphorylation to become active (e.g., lamivudine, zalcitabine, ribavirin, stavudine, and zidovudine) could interfere with the intracellular phosphorylation and activity of cladribine. Prevention or Management Avoid concomitant use.

7.5Potent ENT, CNT and BCRP Transporter Inhibitors Clinical Impact Cladribine is a substrate of breast cancer resistance protein (BCRP), equilibrative nucleoside (ENT1), and concentrative nucleoside (CNT3) transport proteins. The bioavailability, intracellular distribution, and renal elimination of cladribine may be altered by potent ENT1, CNT3, and BCRP transporter inhibitors. Prevention or Management Avoid co-administration of potent ENT1, CNT3, or BCRP transporter inhibitors (e.g., ritonavir, eltrombopag, curcumin, cyclosporine, dilazep, nifedipine, nimodipine, cilostazol, sulindac, dipyridamole, or reserpine) during the 4 to 5 day cladribine treatment cycles.

If this is not possible, consider selection of alternative concomitant drugs with no or minimal ENT1, CNT3, or BCRP transporter inhibiting properties. If this is not possible, dose reduction to the minimum mandatory dose of drugs containing these compounds, separation in the timing of administration, and careful patient monitoring is recommended.

7.6Potent BCRP and P-gp Transporter Inducers Clinical Impact Possible decrease in cladribine exposure if potent BCRP or P-gp transporter inducers are co-administered. Prevention or Management Consider a possible decrease in cladribine efficacy if potent BCRP (e.g., corticosteroids) or P-gp (e.g., rifampicin, St. John's Wort) transporter inducers are co-administered.

Immunosuppressive drugs: Consider overlapping effects on immune system, when used sequentially. Concomitant use not recommended. (7.1) Hematotoxic drugs: Monitor patients for additive effects on the hematological profile.

(7.3) Antiviral and antiretroviral drugs: Avoid concomitant use. (7.4) BCRP or ENT/CNT inhibitors: May alter bioavailability of cladribine. Avoid concomitant use.

(7.5)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Cladribine tablets are contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception. There are no adequate data on the developmental risk associated with use of cladribine in pregnant women. Cladribine was embryolethal when administered to pregnant mice and produced malformations in mice and rabbits [ see Data ].

The observed developmental effects are consistent with the effects of cladribine on DNA [ see Contraindications (4) and Warnings and Precautions (5.2) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal Data When cladribine was administered intravenously (0, 0.5, 1.5, or 3 mg/kg/day) to pregnant mice during the period of organogenesis, fetal growth retardation and malformations (including exencephaly and cleft palate) and embryofetal death were observed at the highest dose tested. An increase in skeletal variations was observed at all but the lowest dose tested. There was no evidence of maternal toxicity.

When cladribine was administered intravenously (0, 0.3, 1, and 3 mg/kg/day) to pregnant rabbits during the period of organogenesis, fetal growth retardation and a high incidence of craniofacial and limb malformations were observed at the highest dose tested, in the absence of maternal toxicity. When cladribine was administered intravenously (0, 0.5, 1.5, or 3 mg/kg/day) to mice throughout pregnancy and lactation, skeletal anomalies and embryolethality were observed at all but the lowest dose tested.

8.2Lactation Risk Summary Cladribine tablets are contraindicated in breastfeeding women because of the potential for serious adverse reactions in breastfed infants [ see Contraindications (4) and Warnings and Precautions (5) ]. Advise women not to breastfeed during dosing with cladribine and for 10 days after the last dose. There are no data on the presence of cladribine in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.

8.3Females and Males of Reproductive Potential Pregnancy Testing In females of reproductive potential, pregnancy should be excluded before the initiation of each treatment course of cladribine [see Use in Specific Populations ( 8.1 )]. Contraception Females Females of reproductive potential should prevent pregnancy by use of effective contraception during cladribine dosing and for at least 6 months after the last dose in each treatment course. Women who become pregnant during cladribine tablets therapy should discontinue treatment [ see Warnings and Precautions (5.2) ].

Males As cladribine interferes with DNA synthesis, adverse effects on human gametogenesis could be expected. Therefore, male patients of reproductive potential should take precautions to prevent pregnancy of their partner during cladribine dosing and for at least 6 months after the last dose in each treatment course [ see Warnings and Precautions (5.2) and Nonclinical Toxicology (13.1) ].

8.4Pediatric Use The safety and effectiveness in pediatric patients (below 18 years of age) have not been established. Use of cladribine is not recommended in pediatric patients because of the risk of malignancies [ see Warnings and Precautions (5.1) ].

8.5Geriatric Use Clinical studies with cladribine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution is recommended when cladribine is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases,…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Cladribine tablets are contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception. There are no adequate data on the developmental risk associated with use of cladribine in pregnant women. Cladribine was embryolethal when administered to pregnant mice and produced malformations in mice and rabbits [ see Data ].

The observed developmental effects are consistent with the effects of cladribine on DNA [ see Contraindications (4) and Warnings and Precautions (5.2) ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal Data When cladribine was administered intravenously (0, 0.5, 1.5, or 3 mg/kg/day) to pregnant mice during the period of organogenesis, fetal growth retardation and malformations (including exencephaly and cleft palate) and embryofetal death were observed at the highest dose tested. An increase in skeletal variations was observed at all but the lowest dose tested. There was no evidence of maternal toxicity.

When cladribine was administered intravenously (0, 0.3, 1, and 3 mg/kg/day) to pregnant rabbits during the period of organogenesis, fetal growth retardation and a high incidence of craniofacial and limb malformations were observed at the highest dose tested, in the absence of maternal toxicity. When cladribine was administered intravenously (0, 0.5, 1.5, or 3 mg/kg/day) to mice throughout pregnancy and lactation, skeletal anomalies and embryolethality were observed at all but the lowest dose tested.

🧒 Pediatric Use 41 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients (below 18 years of age) have not been established. Use of cladribine is not recommended in pediatric patients because of the risk of malignancies [ see Warnings and Precautions (5.1) ].

🧓 Geriatric Use 73 words ▾

8.5Geriatric Use Clinical studies with cladribine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Caution is recommended when cladribine is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases, and other drug therapy.

🆘 Overdosage 98 words ▾

10 OVERDOSAGE There is no experience with overdose of cladribine tablets. Lymphopenia is known to be dose- dependent. Particularly close monitoring of hematological parameters is recommended in patients who have been exposed to an overdose of cladribine tablets [ see Warnings and Precautions (5.3, 5.5) ].

There is no known specific antidote to an overdose of cladribine tablets. Treatment consists of careful observation and initiation of appropriate supportive measures. Discontinuation of cladribine tablets may need to be considered.

Because of the rapid and extensive intracellular and tissue distribution, hemodialysis is unlikely to eliminate cladribine to a significant extent.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes.

12.2Pharmacodynamics Cladribine tablets causes a dose-dependent reduction in lymphocyte count. The lowest absolute lymphocyte counts occurred approximately 2 to 3 months after the start of each treatment cycle and were lower with each additional treatment cycle. At the end of Year 2, 2% of patients continued to have absolute lymphocyte counts less than 500 cells per microliter.

The median time to recovery from lymphocyte counts less than 500 cells per microliter to at least 800 cells per microliter was approximately 28 weeks [ see Warnings and Precautions (5.3) ].

12.3Pharmacokinetics Cladribine is a prodrug that becomes active upon phosphorylation to its 2-chlorodeoxyadenosine triphosphate (Cd-ATP) metabolite. The pharmacokinetic parameters presented below were assessed following oral administration of cladribine 10 mg, unless otherwise specified. The cladribine mean maximum concentration (C max ) was in the range of 22 to 29 ng/ mL and corresponding mean AUC was in the range of 80 to 101 ng·h/mL.

The C max and AUC of cladribine increased proportionally across a dose range from 3 to 20 mg. No accumulation of cladribine concentration in plasma was observed after repeated dosing. Absorption The bioavailability of cladribine was approximately 40%.

Following fasted administration of cladribine, the median time to maximum concentration (T max ) was 0.5 h (range 0.5 to 1.5 hours). Effect of Food Following administration of cladribine with a high fat meal, the geometric mean C max decreased by 29% and AUC was unchanged. The T max was prolonged to 1.5 hours (range 1 to 3 hours).

This difference is not expected to be clinically significant. Distribution Cladribine mean apparent volume of distribution ranges from 480 to 490 liters. The plasma protein binding of cladribine is 20% and is independent of concentration, in vitro .

Intracellular concentrations of cladribine and/or its metabolites in human lymphocytes were approximately 30 to 40 times extracellular, in vitro . Cladribine has the potential to penetrate the blood brain barrier. A cerebrospinal fluid/plasma concentration ratio of approximately 0.25 was observed in cancer patients.

Elimination Cladribine estimated terminal half-life is approximately 1 day. The intracellular half-life of the cladribine phosphorylated metabolites cladribine monophosphate (Cd-AMP) is 15 hours and Cd- ATP is 10 hours. Cladribine estimated median apparent renal clearance is 22.2 liter per hour and non-renal clearance is 23.4 liter per hour.

Metabolism Cladribine is a prodrug that is phosphorylated to Cd-AMP by deoxycytidine kinase (and also by deoxyguanosine kinase in the mitochondria) in lymphocytes. Cd-AMP is further phosphorylated to cladribine diphosphate (Cd-ADP) and the active moiety Cd-ATP. The dephosphorylation and deactivation of Cd-AMP is catalyzed by cytoplasmic 5’-nucleotidase (5’-Ntase).

The metabolism of cladribine in whole blood has not been fully characterized. However, extensive whole blood and negligible hepatic enzyme metabolism was observed, in vitro. Excretion After administration of 10 mg oral cladribine in MS patients, 28.5 [20] (mean [SD]) percent of the dose was excreted unchanged via the renal route.

Renal clearance exceeded the glomerular filtration rate, indicating active renal secretion of cladribine. Specific Populations No studies have been conducted to evaluate the pharmacokinetics of cladribine in elderly or in patients with renal or hepatic impairment. There were no clinically significant differences in the pharmacokinetics of cladribine based on age (range 18 to 65 years) or gender.

The effect of hepatic impairment on the pharmacokinetics of cladr…

🧬 Mechanism of Action 45 words ▾

12.1Mechanism of Action The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Cladribine tablets, 10 mg, are white to off white, round, biconvex tablets debossed with “10” on one side and plain on the other side. Each tablet is packaged in a child-resistant day pack containing one or two tablets in a blister card. Dispense one box for each treatment cycle with a Medication Guide [ see Dosage and Administration (2.2) ].

Presentations NDC 60505-4791-4 NDC 60505-4791-5 NDC 60505-4791-6 NDC 60505-4791-7 NDC 60505-4791-8 NDC 60505-4791-9 NDC 60505-4791-1 Box of 4 tablets: Four day packs each containing one tablet. Box of 5 tablets: Five day packs each containing one tablet. Box of 6 tablets: One day pack containing two tablets.

Four day packs each containing one tablet. Box of 7 tablets: Two day packs each containing two tablets. Three day packs each containing one tablet.

Box of 8 tablets: Three day packs each containing two tablets. Two day packs each containing one tablet. Box of 9 tablets: Four day packs each containing two tablets.

One day pack containing one tablet. Box of 10 tablets: Five day packs each containing two tablets.

16.2Storage and Handling Store at controlled room temperature, 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 in original package in order to protect from moisture. Cladribine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures [see References ( 15 )] . 1

📋 Description 154 words ▾

11 DESCRIPTION Cladribine tablets contains the nucleoside metabolic inhibitor cladribine, which is a white to off-white crystalline powder with the molecular formula C 10 H 12 ClN 5 O 3 and molecular weight 285.69 g/mol. It differs in structure from the naturally occurring nucleoside, deoxyadenosine, by the substitution of chlorine for hydrogen in the 2-position of the purine ring. The chemical name of cladribine is 2-chloro-2′-deoxy-adenosine.

The structural formula is shown below: Cladribine is stable at slightly basic and at neutral pH. The main degradation pathway is hydrolysis and at acidic pH significant decomposition occurs with time. The ionization behavior of the molecule over the pH range 0 to 12 is characterized by a single pKa of approximately 1.21.

Cladribine tablets are provided as 10 mg tablet for oral use. Each 10 mg tablet contains cladribine as an active ingredient and magnesium stearate and sorbitol as inactive ingredients. Cladribine tablets also contain hydroxypropyl betadex.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Malignancies Inform patients that cladribine tablets may increase their risk of malignancies. Instruct patients to follow standard cancer screening guidelines [see Dosage and Administration ( 2 ) and Warnings and Precautions ( 5.1 )].

Risk of Teratogenicity Inform patients that cladribine tablets may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant. Before initiating each treatment course, inform patients about the potential risk to the fetus, if female patients or partners of male patients get pregnant during cladribine tablets dosing or within 6 months after the last dose in each treatment course [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 , 8.3 )] .

Instruct female patients of childbearing potential to use effective contraception during cladribine tablets dosing and for at least 6 months after the last dose in each treatment course to avoid pregnancy. Instruct male patients to take precautions to prevent pregnancy of their partner during cladribine tablets dosing and for at least 6 months after the last dose in each treatment course. Advise patients that female patients or partners of male patients who get pregnant immediately inform their healthcare provider.

Lactation Inform women that they cannot breastfeed on a cladribine treatment day and for 10 days after the last dose [see Use in Specific Populations ( 8.2 )] . Lymphopenia and Other Hematologic Toxicity Inform patients that cladribine tablets decreases lymphocyte counts and may also decrease counts of other blood cells. A blood test should be obtained before starting a treatment course, 2 and 6 months after start of treatment in each treatment course, periodically thereafter, and when clinically needed.

Advise patients to keep all appointments for lymphocyte monitoring during and after cladribine treatment [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.3 , 5.5 )]. Infections Inform patients that infections, some of which were serious, have been reported in patients receiving cladribine tablets. Instruct patients to notify their healthcare provider promptly if fever or other signs of infection such as aching, painful muscles, headache, generally feeling unwell or loss of appetite occur while on therapy or after a course of treatment [ see Warnings and Precautions (5.4) ].

Advise patients that PML has happened with parenteral cladribine used in oncologic indications. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML.

Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [ see Warnings and Precautions (5.4) ] . Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during and after treatment with cladribine tablets. Advise patients to complete any live or live-attenuated vaccinations at least 4 to 6 weeks prior to initiation of cladribine tablets.

Instruct patients to contact their healthcare provider prior to receiving any vaccinations. Liver Injury Inform patients that liver injury has been reported in patients receiving cladribine tablets. Instruct patients treated with cladribine tablets to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

A blood test should be obtained prior to each treatment cycle and course with cladrib…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Cladribine (klad′ ri been) Tablets, for oral use Medication Guide available at https://www.apotex.com/products/us/mg.asp What is the most important information I should know about cladribine tablets? Cladribine tablets can cause serious side effects, including: Risk of cancer (malignancies). Treatment with cladribine tablets may increase your risk of developing cancer.

Talk to your healthcare provider about your risk of developing cancer if you receive cladribine tablets. You should follow your healthcare provider's instructions about screening for cancer. Cladribine tablets may cause birth defects if used during pregnancy.

Women must not be pregnant when they start treatment with cladribine tablets or become pregnant during cladribine tablets dosing and within 6 months after the last dose of each yearly treatment course. Stop your treatment with cladribine tablets and call your healthcare provider right away if you become pregnant during treatment with cladribine tablets. For women who are able to become pregnant: Your healthcare provider should order a pregnancy test for you before you begin your first and second yearly treatment course of cladribine tablets to make sure that you are not pregnant.

Your healthcare provider will decide when to do the test. Use effective birth control (contraception) on the days on which you take cladribine tablets and for at least 6 months after the last dose of each yearly treatment course. Ask your healthcare provider which contraception method is right for you.

For men with female partners who are able to become pregnant: Use effective birth control (contraception) during the days on which you take cladribine tablets and for at least 6 months after the last dose of each yearly treatment course. What are cladribine tablets? Cladribine tablets are prescription medicine used to treat relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults.

Because of its risks, cladribine tablets are generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough. Cladribine tablets are not recommended for use in people with clinically isolated syndrome (CIS). It is not known if cladribine tablets are safe and effective in children under 18 years of age.

Do not take cladribine tablets if you: have cancer (malignancy). are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control. See “ What is the most important information I should know about cladribine tablets? ” are human immunodeficiency virus (HIV) positive. have active infections, including tuberculosis (TB), hepatitis B or C. are allergic to cladribine. are breastfeeding. See “ Before you take cladribine tablets, tell your healthcare provider about all of your medical conditions, including if you: ” Before you take cladribine tablets, tell your healthcare provider about all of your medical conditions, including if you: think you have an infection. have heart failure. have liver or kidney problems. have taken, take, or plan to take medicines that affect your immune system or your blood cells, or other treatments for MS.

Certain medicines can increase your risk of getting an infection. have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live- attenuated vaccines within the 4 to 6 weeks before you start your treatment with cladribine tablets. You should not receive these types of vaccines during your treatment with cladribine tablets and until your healthcare provider tells you that your immune system is no longer weakened. have or have had cancer. are breastfeeding or plan to breastfeed.

It is not known if cladribine passes into your breast milk. Do not breastfeed on the days on which you take cladribine tablets, and for 10 days after the last dose. See “ Do not take cladribine tablets if you:” Tell your healthc…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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