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Cat Hair, Standardized 10000 [BAU]/mL Injection, Solution, 50 mL
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cat Hair, Standardized 10000 [BAU]/mLthis 00268-2000-50 | ALK-Abello, | 50 ml | — | — | FDA listed | — |
| Cat Hair, Standardized 10000 [BAU]/mL 00268-2001-06 | ALK-Abello, | 5 ml | — | — | FDA listed | — |
| Standardized Cat Hair 10000 [BAU]/mL 49643-0705-05 | Allermed | 5 ml | — | — | FDA listed | — |
| Standardized Cat Hair 10000 [BAU]/mL 65044-4815-01 | Jubilant | 5 ml | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00268-2000-10 | 10 mL in 1 VIAL, MULTI-DOSE (0268-2000-10) | 2003-11-28 | Active |
| 00268-2000-50 You're viewing this | 50 mL in 1 VIAL, MULTI-DOSE (0268-2000-50) | 2003-11-28 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 00268-2000-50?
What is the difference between NDC 00268-2000-50 and NDC 00268-2000-10?
What NDC number is used to bill for this package of Cat Hair, Standardized 10000 [BAU]/mL Injection, Solution?
🧭 About this NDC listing & data coverage
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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Where does this data come from?
📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNING This product should be used only by or under the direction of physicians experienced in administering allergens to the maximum tolerated dose and the emerg ency treatment of anaphylaxis, and only where adequate means for treating severe systemic reactions are immediately available . This standardized cat hair extract is not interchangeable with non-standardized extracts, cat pelt extracts or with extracts labeled in allergy units per mL (AU/mL). See Description , Warnings , and Dosage and Administration sections for further information.
Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death 1 . Because of the possibility of severe systemic reactions, the patient should be instructed in the recognition of anaphylactic symptoms, observed in the office for 20 to 30 minutes after each injection, and warned to return to the office if symptoms of an allergic reaction occur. Serious adverse events should be reported to the FDA MedWatch Program: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787, (1 -800-FDA-1088) Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators, and the risk of severely complicating the treatment of systemic reactions should be carefully considered before a decision to treat is reached.
Care should also be taken with patients with unstable or steroid-dependent asthma, or with underlying cardiovascular disease. Before administering this or any allergenic extract, physicians should be thoroughly familiar with the information in this insert, especially the Warnings, Precautions, and Adverse Reactions sections.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Standardized Cat Hair allergenic extracts are indicated for the diagnostic skin testing and immunotherapy of patients whose histories indicate that they experience allergic symptoms upon natural exposure to the specific allergens.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dilution Allergenic extract concentrates must be diluted before use in intradermal skin testing or the initial stages of immunotherapy. As with any parenteral product, always use careful aseptic technique in preparing dilutions, assuring that the vials, diluents, and syringes are sterile, and that the dilutions are prepared under aseptic conditions, Sterile diluents that can be used include Normal Saline, Buffered Saline, 50% glycerin or Albumin Saline (HSA). To obtain the concentrations required for intradermal testing or for the initial stages of immunotherapy, prepare serial 5 or 10 fold dilutions of the concentrate, to achieve the concentrations specified in Table 2 or 3, below.
The relatively small 0.5 ml volume conserves the original concentrate, and is convenient because sterile diluent is readily available in prefilled 2.0 and 4.5 ml volumes. Table 2 Examples of Ten-fold Dilution Series Dilution Number Add This Volume/Dilution of Extract To this Diluent Volume To Obtain Extract at the Following Concentration (BAU/ml) 0 1 2 3 4 5 6 Concentrate 0.5 ml concentrate 0.5 ml dilution #1 0.5 ml dilution #2 0.5 ml dilution #3 0.5 ml dilution #4 0.5 ml dilution #5 __ 4.5 ml 4.5 ml 4.5 ml 4.5 ml 4.5 ml 4.5 ml 10,000 1,000 100 10 1.0 0.10
0.01Table 3 Examples of Five-fold Dilution Series Dilution Number Add This Volume/Dilution of Extract To this Diluent Volume To Obtain Extract at the Following Concentration (BAU/ml) 0 1 2 3 4 5 6 Concentrate 0.5 ml concentrate 0.5 ml dilution #1 0.5 ml dilution #2 0.5 ml dilution #3 0.5 ml dilution #4 0.5 ml dilution #5 __ 2.0 ml 2.0 ml 2.0 ml 2.0 ml 2.0 ml 2.0 ml 5,000 1,000 200 40 8 1.6
0.32For each vial, record the date of dilution on the label. Skin Testing Scratch or prick-puncture testing should be performed using the 10,000 BAU/ml concentrate, a negative control (diluent) and a positive control (histamine 1.8 mg/ml). Extract for intradermal testing can be prepared by diluting the concentrate with any appropriate aqueous sterile diluent, as described above.
A 100 BAU/ml concentration is also available for intradermal testing. The following skin testing protocol can be recommended: The location for both prick and intradermal testing is usually the flexor surface of the forearm. Use aseptic technique throughout.
Perform a preliminary skin prick test with the extract concentrate, by placing a drop of the extract on the skin and then using a needle to prick the skin gently through the drop. Use a normal diluent as negative control and histamine as a positive control. Read the test after 15 minutes.
Patients reacting strongly to the prick test should be considered highly sensitive to the extract, and suitable precautions should be taken. A suggested grading system appears in Table 4. If the histamine control is negative, the possibility of skin non-reactivity must be considered.
Begin intradermal testing, generally starting at the 100 BAU/ml dilution if the prick test was negative, or at 0.1 or
0.01BAU/ml if the test was positive or if no prick test was done. Use a separate, sterilized syringe and needle for each extract and each patient. Introduce the needle into the superficial skin layers until the bevel is completely buried, then slowly inject approximately 0.02 - 0.05 ml.
Measure the wheal and erythema after 15 minutes, and determine the degree of response to the injection, in comparison to the negative control. A suggested grading system appears in Table 5. If the intradermal reaction is negative at the initial concentration, continue intradermal testing with 10-fold increments in the concentration until a clearly positive response has been obtained or a peak concentration of 100 BAU/ml has been tested, whichever occurs first.
Table 4 Skin Test Grading System 12 Grade Wheal Results 0 + ++ +++ ++++ No Wheal/same size as negative <Half the Histamine Diameter Half the Histamine Diameter Same Size as Histamine Control Size of Histamine Control +2mm Table 5 Intrade…
⛔ Contraindications ▾
CONTRAINDICATIONS The product is contraindicated for use in subjects who are not clinically allergic to the specified allergen, or who are not reactive to ALK-Abelló extract. No other absolute contraindications to immunotherapy with allergenic extracts are known. However, the risk of serious systemic anaphylactic reactions to any potent allergenic extract suggests a number of preexisting conditions that should be considered relative contraindications.
Among those conditions are acute infections, immune disease, severe cardiac disease pulmonary diseases such as asthma with a significant irreversible component, and treatment with β-adrenergic antagonist drugs (''beta-blockers''). See also Warnings , Precautions , and Adverse Reactions .
⚠️ Warnings ▾
WARNINGS See additional warnings given in the box at the beginning of this insert. Do not use this extract or allow its use until you have read this insert, and have taken adequate precautions to prevent inadvertent dosage errors. See Dosage and Administration for further information.
Some patients are highly sensitive to allergenic extracts, and in such patients even a small skin test dose could result in a serious systemic reaction. Adequate means to treat such reactions must be immediately available, including the following equipment 8 : stethoscope and sphygmomanometer; tourniquets, syringes, hypodermic needles, and large-bore (14 gauge) needles; aqueous epinephrine HCI 1:1000;oxygen, intravenous fluids and the equipment for administering them; oral airway; diphenhydramine or similar antihistamine; aminophylline and corticosteroids for intravenous injection; and vasopressor.
Observing the following precautions will reduce the risk of serious systemic reactions: Do not begin immunotherapy without establishing the appropriate initial dose by skin testing (see Dosage and Administration ), and do not inject the undiluted extract concentrate at any time unless tolerance has been demonstrated. When changing to an extract from a different manufacturer establish the proper dosage by skin testing. When changing to a different lot of extract, reduce the dose by 50-75%; this is particularly important after using an extract that is near its expiration date.
Take care to properly prepare, label store and control all dilutions. Use caution in dosing of high-risk steroid-dependent labile asthmatics. DO NOT GIVE INTRAVENOUSLY.
After inserting the needle subcutaneously, but before injecting the dose, retract the plunger of the syringe slightly. If blood appears in the syringe, discard the syringe and its contents and repeat the injection at another site. Subcutaneous injection is recommended because intracutaneous or intramuscular injections are more likely to produce local reactions.
Observe the patient at 20 to 30 minutes after injection, and be alert for the signs of impending reaction. Make sure the patient understands that serious delayed reactions can occur later on, how to recognize them, and what to do if they occur. Patients who are receiving beta-blocking medication are high-risk patients for immunotherapy, because systemic reactions to the extract may be more severe in such patients 9 , and because the beta-blocker may impair the ability to reverse the reaction 10 in such patients.
This risk should be carefully weighed before a decision to treat is reached. Care should also be taken with patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease. This and any allergenic extract should be temporarily withheld or its dosage reduced under any of these conditions 11 : When the patient has an unexpectedly severe local or any systemic reaction to the previous dose.
If the patient is experiencing allergic symptoms such as rhinitis or asthma or is ill with flu or infection accompanied by fever. If an unusually long time has passed since the previous injection. If the patient is exposed to excessive amounts of clinically relevant allergen prior to therapy.
Allergic patients differ widely in their sensitivity to this or any allergenic extract, and no single dosage regimen can be recommended for all patients. Progression to the next higher dose requires tolerance of the previous one, and the regimen must be modified if any of the conditions described above occur. Such modifications should include weaker dilutions and smaller dosage increments.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Severe anaphvlactic reactions to this extract can occur in extremely allergic patients and at any dosage level. Do not use this extract unless you are prepared to deal with these reactions, and until you have read and understood the warnings, precautions, and dosage and administration sections of this insert. The most serious systemic reaction that can occur is anaphylactic shock which while rare, is life threatening and must be treated immediately.
Among other systemic reactions that have occurred are laryngeal edema, fainting, pallor bradycardia, hypotension, bronchospasm, angioedema, cough, sneezing, conjunctivitis, rhinitis, and urticaria. Should a serious systemic reaction occur: Inject 0.3-0.5 ml of 1:1000 epinephrine into the opposite arm; this may be repeated every 5 to 10 minutes, as a succession of smaller doses is more effective and less dangerous than a single larger one. Use a smaller dose for infants and children, in the range of 0.01 ml/kg of body weight.
Apply a tourniquet proximal to the injection site; loosen it at least every 10 minutes interval. Inject no more than 0.1 ml of 1:1000 epinephrine at the injection site, to delay the absorption of the remaining extract. Beta adrenergic agonists or aminophylline may be helpful in alleviating bronchospasm and airway obstruction.
Other treatments that may be of benefit include H 1 antihistamines (e.g., 1 mg/kg diphenhydramine) and glococorticoids (e.g., 120 mg methylprednisolone). These measures will almost always reverse the reaction but in the rare instances when they do not, then the full armamentarium of emergency medicine may be required, among them: direct laryngoscopy direct current cardioversion, tracheotomy, and intracardiac injection of drugs 8 . The occurrence of a severe systemic reaction to an injection of this extract does not contraindicate further therapy, but the next dose given should be reduced by at least 90% and raised very slowly thereafter.
If a pattern of systemic reactions- even very mild ones- appears, then the benefits of continued treatment must be carefully weighed against the substantial demonstrated risk. Local reactions, even relatively severe but transient redness, swelling and discomfort, are the normal physiologic response to the allergens and to the volume of the fluid injected, and in their milder forms are not unexpected. Local reactions generally subside quickly and do not require treatment, but application of cold to the injection site or other symptomatic measures may be useful.
However, severe local reactions should be considered a warning of potential systemic reaction if that dosage is continued. Always reduce the dose substantially if such a local reaction occurs. Overdosage: See Adverse Reactions section.
🤰 Pregnancy ▾
Pregnancy Category C: Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.
On the basis of histamine's known ability to contract uterine muscle any reaction that would release significant amounts of histamine whether occurring from allergen exposure or immunotherapy overdose, should be avoided.
🧒 Pediatric Use ▾
Pediatric Use : Clinical studies of allergenic extracts did not include sufficient numbers of pediatric patients to determine whether they respond differently from older patients. Other reported clinical experience has not identified differences in responses between pediatric and adult patients. In general, dose selection for a pediatric patient should be cautious, usually starting at the low end of the dosing range.
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies of allergenic extracts have not included 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
Overdosage: See Adverse Reactions section.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in vial sizes of 1, 5 and 10 ml at a concentration of 100 BAU/ml; and the Scratch test products are available in 3 ml and 5 ml dropper vials at a concentration of 10,000 BAU/ml. To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.
Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician. Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label.
Extracts that contain less than 50% v/v glycerin are less stable,
📋 Description ▾
DESCRIPTION Standardized cat hair extract is manufactured from source material obtained from the wash of cat hair clippings, which is then concentrated and absorbed onto powdered cat hair. Cat albumin and other serum-related non-Fel d 1 allergens, found in cat pelt extracts, have not been included in this extract. Cat albumin is not an important allergen for 80% of cat-sensitive patients 2 .
They are supplied as sterile solutions for scratch, intradermal or subcutaneous administration. The inactive ingredients are as shown in Table 1. Table 1 Allergenic Extracts, Inactive Ingredients Extract Formulation Ingredient Concentration (%) Glycerinated Sodium Chloride Sodium Bicarbonate Glycerin 0.5 0.25 50 (v/v) Standardized cat hair extracts containing 10 to19.9 Fel d 1 units per ml are assigned 10,000 Bioequivalent Allergy Units per ml (BAU/mI) based on quantitative skin testing 3 .
Standardized cat hair extracts containing 5 to
9.9Fel d 1 units per ml are assigned 5,000 BAU/ml. Isoelectric focusing (IEF) patterns of these standardized cat extracts have been shown to be predictive of the presence of non-Fel d 1 allergens. IEF has been adopted by the FDA as a release criterion.
Therefore, all lots of Standardized Cat Hair extract are required to be compared by IEF to Center for Biologics Evaluation and Research (CBER) Cat Hair Extract Reference 4 . Allergenic extracts must be diluted before use in intradermal diagnosis or in the initial stages of treatment .
💬 Information for Patients ▾
Information For Patients: The patient should be told to remain in the office for 20 to 30 minutes after injection, and be alert for the signs of impending reaction. The patient should be instructed that serious delayed reactions can occur later on and that these must be reported to the physician immediately. These reactions include swelling or tenderness at the site of injection, rhinorrhea sneezing, coughing, shortness of breath nausea dizziness wheezing, rash or faintness.