Cyclosporine .5 mg/mL Emulsion — NDC 0378-8760-91 (Billing 00378-8760-91)
This is a package of Cyclosporine .5 mg/mL Emulsion from Mylan Pharmaceuticals Inc., marketed since Feb 2022 and currently FDA-listed; retail pharmacies pay about $0.9095 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0378-8760-91 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0378 labeler · 8760 product · 91 package
- Package marketed since
- Feb 3, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0303788760587, 0303788760914
- Medicaid fills, this package
- 4,034 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 051820
- GCN: 19216
- GPI-14 (Medi-Span): 86720020001621
- HICL (First Databank): 004524
- AHFS class code: 52:08.00.00
- RxCUI (RxNorm): 2572292
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Calcineurin Inhibitor Immunosuppressant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Oral forms help prevent organ rejection after kidney, liver or heart transplants. Some oral products also treat severe rheumatoid arthritis and severe pl...
- Oral modified forms like Neoral and Gengraf are taken twice a day. Keep your timing and meal routine consistent from day to day. Follow your prescriber's directions and the label.
- No, avoid grapefruit and grapefruit juice. They raise cyclosporine levels in your blood, which can increase side effects.
- Not on your own. Modified products such as Neoral and Gengraf are not interchangeable with Sandimmune, and switching needs your doctor's supervision and extra blood level checks.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cyclosporine — tap one for details:
Cyclosporine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.910 | $54.57 / 60 vials |
| Medicaid paysCMS SDUD · 12 mo | $2.74 | $164.63 / 60 vials |
| Medicare drug plans payPart D · Q2 2026 | $3.98 | $238.91 / 60 vials |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00378-8760-58 0378-8760-58 | 6 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE | $1.18 / ea | $35.41 | 2022-02-03 | — | Active |
| 00378-8760-91 You're viewing this Main listing | 12 POUCH in 1 CARTON / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE | $0.9095 / ea | $54.57 | 2022-02-03 | — | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.9095 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 83% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Cyclosporine .5 mg/mL Emulsion?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyclosporine .5 mg/mLthis 00378-8760-91 | Mylan | 12 pouches | $0.909 | AB | Availability likely | — |
| Cyclosporine .5 mg/mL 24979-0126-18 | Upsher-Smith | 60 vials | $0.909 | AB | Availability likely | — |
| Cyclosporine .5 mg/mL 00480-4076-30 | Teva | 6 pouches | $1.180 | AB | Availability likely | +30% |
| Cyclosporine .5 mg/mL 10702-0808-03 | KVK-TECH, | 30 vials | $1.180 | AB | Availability likely | +30% |
| Cyclosporine .5 mg/mL 60505-6202-01 | Apotex | 30 vials | $1.180 | AB | Availability likely | +30% |
| Cyclosporine .5 mg/mL 68180-0214-30 | Lupin | 30 vials | $1.180 | AB | Availability likely | +30% |
| Cyclosporine .5 mg/mL 71656-0012-30 | Saptalis | 6 pouches | $1.180 | AB | Availability likely | +30% |
| Cyclosporine .5 mg/mL 73043-0005-01 | Devatis | 3 pouches | $1.180 | AB | Availability likely | +30% |
| Restasis MultiDose .5 mg/mL 00023-5301-05 | Allergan, | 1 bottle | $112.322 | AB | Availability likely | +12251% |
| Restasis .5 mg/mL 00023-9163-12 | Allergan, | 5 vials | — | AB | FDA listed | — |
| Restasis .5 mg/mL 50090-4476-00 | A-S | 30 vials | — | AB | FDA listed | — |
| Cyclosporine .5 mg/mL 69238-1023-03 | Amneal | 3 pouches | — | AB | Discontinued | — |
| Cyclosporine .5 mg/mL 69097-0292-03 | Cipla | 2 pouches | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
🧪 Avoiding an ingredient? See Cyclosporine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 71DD5V995L
A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
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UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Mylan Pharmaceuticals Inc. labeler code 00378
- Methylphenidate 1.1 mg/h Patch NDC 0378-8260-93
- Methylphenidate 1.6 mg/h Patch NDC 0378-8261-93
- Methylphenidate 2.2 mg/h Patch NDC 0378-8262-93
- Methylphenidate 3.3 mg/h Patch NDC 0378-8263-93
- Albuterol Sulfate 2.5 mg/3mL Solution NDC 0378-8270-52
- Clindamycin Phosphate and Benzoyl Peroxide Kit NDC 0378-8688-35
- Buprenorphine and Naloxone 2 mg; .5 mg Film NDC 0378-8765-93
- Buprenorphine and Naloxone 4 mg; 1 mg Film NDC 0378-8766-93
- Buprenorphine and Naloxone 8 mg; 2 mg Film NDC 0378-8767-93
- Buprenorphine and Naloxone 12 mg; 3 mg Film NDC 0378-8768-93
- Estradiol .1 mg/g Cream NDC 0378-8770-35
- Loratadine 10 mg Tablet NDC 0378-8880-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of cyclosporine ophthalmic emulsion twice a day in each eye approximately 12 hours apart. Cyclosporine ophthalmic emulsion can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products.
Discard vial immediately after use. Instill one drop of cyclosporine ophthalmic emulsion twice a day in each eye approximately 12 hours apart. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing cyclosporine 0.5 mg/mL Cyclosporine ophthalmic emulsion 0.5 mg/mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. • Hypersensitivity ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. ( 5.1 )
5.1Potential for Eye Injury and Contamination Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination.
5.2Use with Contact Lenses Cyclosporine ophthalmic emulsion should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic emulsion.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Potential for Eye Injury and Contamination [ see Warnings and Precautions (5.1) ] The most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience 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. In clinical trials, the most common adverse reaction following the use of cyclosporine opthalmic emulsion was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
6.2Post-marketing Experience The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion. 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. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [ see Clinical Pharmacology (12.3) ], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [ see Data ]. Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations.
These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.
An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).
8.2Lactation Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion [see Clinical Pharmacology (12.3) ] , caution should be exercised when cyclosporine ophthalmic emulsion is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cyclosporine ophthalmic emulsion and any potential adverse effects on the breast-fed child from cyclosporine.
8.4Pediatric Use Safety and efficacy have not been established in pediatric patients below the age of 16.
8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [ see Clinical Pharmacology (12.3) ], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [ see Data ]. Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations.
These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.
An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy have not been established in pediatric patients below the age of 16.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
12.3Pharmacokinetics Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of cyclosporine ophthalmic emulsion 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with cyclosporine ophthalmic emulsion.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Cyclosporine ophthalmic emulsion, 0.05% is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.5 mL natural colored low density polyethylene vial; five vials are packaged in an aluminum pouch and six pouches are packaged in a carton. The entire contents of each carton (30 vials) must be dispensed intact.
Cyclosporine ophthalmic emulsion is also provided in a 60 count carton that must be dispensed intact. NDC 0378-8760-58 carton of 30 vials NDC 0378-8760-91 carton of 60 vials Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
📋 Description ▾
11 DESCRIPTION Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl-L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.6 Cyclosporine, USP is a white or almost white powder.
Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine USP, 0.05%.
Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Handling the Container Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the vial tip to their eye to avoid the potential for injury to the eye [ see Warnings and Precautions (5.1) ] Use with Contact Lenses Cyclosporine ophthalmic emulsion should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses.
Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic emulsion [ see Warnings and Precautions (5.2) ]. Administration Advise patients that the emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration.
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in U.S.A.
JANUARY 2022
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of cyclosporine ophthalmic emulsion 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with cyclosporine ophthalmic emulsion.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. Cyclosporine ophthalmic emulsion demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of cyclosporine ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients.
Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. No increase in bacterial or fungal ocular infections was reported following administration of cyclosporine ophthalmic emulsion.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value. In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level.
The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose of one drop (approximately 28 mcL) of 0.05% cyclosporine ophthalmic emulsion twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Mutagenesis Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice.
A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitr o gave indication of a positive effect (i.e., induction of SCE). Impairment of Fertility No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value. In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level.
The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose of one drop (approximately 28 mcL) of 0.05% cyclosporine ophthalmic emulsion twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Mutagenesis Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice.
A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitr o gave indication of a positive effect (i.e., induction of SCE). Impairment of Fertility No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-58 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 30 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using.
Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (30 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 1
PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-91 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 60 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using.
Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (60 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 2