Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Plant Allergenic Extract [EPC]
Tangerine (Citrus reticulata) allergenic extract is a non-standardized biological product used primarily in the diagnosis and treatment of citrus-related Type I hypersensitivities. It belongs to the Non-Standardized Plant Allergenic Extract class of diagnostic and therapeutic agents.
Name
Tangerine
Raw Name
TANGERINE
Category
Non-Standardized Plant Allergenic Extract [EPC]
Drug Count
3
Variant Count
3
Last Verified
February 17, 2026
About Tangerine
Tangerine (Citrus reticulata) allergenic extract is a non-standardized biological product used primarily in the diagnosis and treatment of citrus-related Type I hypersensitivities. It belongs to the Non-Standardized Plant Allergenic Extract class of diagnostic and therapeutic agents.
Detailed information about Tangerine
References used for this content
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Tangerine.
Tangerine allergenic extract is a complex biological solution derived from the fruit or peel of the Citrus reticulata plant. In a clinical pharmacology context, it is classified by the FDA as a Non-Standardized Plant Allergenic Extract [EPC] and a Non-Standardized Food Allergenic Extract [EPC]. Unlike standardized extracts (such as those for ragweed or grass), the potency of tangerine extract is not measured in Bioequivalent Allergy Units (BAU) but is instead prepared based on weight-to-volume (w/v) ratios or Protein Nitrogen Units (PNU). This medication is primarily utilized by board-certified allergists and immunologists for two distinct purposes: the diagnostic identification of specific IgE-mediated allergies (via skin testing) and the therapeutic desensitization of patients through allergen immunotherapy (AIT).
Tangerine belongs to a class of drugs called allergenic extracts, which are designed to interact directly with the patient's immune system. The history of these extracts dates back to the early 20th century, with the FDA's Center for Biologics Evaluation and Research (CBER) maintaining regulatory oversight. Because tangerine is a non-standardized extract, its composition includes a wide array of proteins, glycoproteins, and polysaccharides inherent to the fruit. The primary allergenic components identified in citrus species often include lipid transfer proteins (LTPs), such as Cit r 3, which are known for their stability and potential to cause systemic reactions.
The mechanism of action for tangerine extract depends on its clinical application. In diagnostic testing (Skin Prick Testing or Intradermal Testing), the extract is introduced into the epidermis or dermis. If the patient has been previously sensitized to tangerine allergens, specific Immunoglobulin E (IgE) antibodies bound to the surface of mast cells and basophils will recognize the tangerine proteins. This recognition triggers a cross-linking of IgE receptors, leading to the immediate degranulation of these cells. This process releases inflammatory mediators, most notably histamine, leukotrienes, and prostaglandins, which cause localized vasodilation and capillary permeability. The clinical result is a 'wheal and flare' reaction—a raised bump surrounded by redness—which serves as a visual confirmation of sensitization.
In allergen immunotherapy (AIT), the mechanism shifts from provocation to modulation. By administering gradually increasing doses of the tangerine extract via subcutaneous injection, the clinician aims to induce 'immunological tolerance.' At the molecular level, this involves a shift in the T-cell response from a Th2-dominated profile (which promotes IgE production) to a Th1 or Treg (regulatory T-cell) profile. This shift increases the production of 'blocking antibodies,' specifically IgG4, which can intercept the allergen before it reaches the IgE on mast cells. Over time, this reduces the sensitivity of the immune system, potentially preventing anaphylaxis upon accidental exposure to the fruit.
Traditional pharmacokinetic parameters (like those for oral tablets) are difficult to apply to allergenic extracts because they are not intended to reach a systemic 'steady state' concentration in the blood.
Tangerine allergenic extract is FDA-indicated for the following:
Off-label uses may include specialized 'Prick-to-Prick' testing using fresh fruit alongside the commercial extract to increase diagnostic sensitivity, as some volatile allergens may be lost during the manufacturing process of the extract.
Tangerine extract is typically available in the following formats:
> Important: Only your healthcare provider can determine if Tangerine is right for your specific condition.
Dosage for tangerine allergenic extract is highly individualized and must be determined by an allergy specialist based on the patient's sensitivity levels. There is no 'one-size-fits-all' dose for biological extracts.
Tangerine allergenic extract is used in children; however, the starting doses are often more conservative. Children under the age of 5 may be at higher risk for systemic reactions because they may not be able to articulate early symptoms of anaphylaxis. Pediatric dosing follows the same 'start low and go slow' escalation used in adults, but the physician must weigh the risk of treatment against the severity of the allergy.
No specific dose adjustments are provided in the manufacturer labeling for renal impairment. However, patients with severely compromised kidney function may have altered clearance of inflammatory mediators released during a reaction.
No dosage adjustments are required for hepatic impairment, as the metabolism of the extract proteins does not rely on the cytochrome P450 system.
Elderly patients (over 65) require cautious dosing. The presence of underlying cardiovascular disease in this population increases the risk of a fatal reaction if anaphylaxis occurs. Furthermore, many elderly patients take beta-blockers, which are a relative contraindication for immunotherapy.
Tangerine allergenic extract is never for self-administration at home. It must be administered in a clinical setting equipped with emergency resuscitation equipment.
If an immunotherapy dose is missed, the next dose may need to be reduced depending on how much time has passed. If more than 4 weeks have passed since the last dose, the physician will typically drop the dose back several levels in the build-up schedule to prevent a reaction due to lost tolerance.
An overdose of tangerine extract (receiving a dose higher than the patient's current tolerance) can lead to immediate anaphylactic shock. Symptoms include generalized hives, swelling of the throat, wheezing, and a drop in blood pressure. Treatment requires immediate intramuscular epinephrine, oxygen, and IV fluids.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Side effects are extremely common with allergenic extracts as they are designed to provoke an immune response. Localized reactions are the most frequent.
> Warning: Stop taking Tangerine and call your doctor immediately or seek emergency care if you experience any of these symptoms of anaphylaxis.
There are no known long-term 'toxic' effects of tangerine extract on organs like the liver or kidneys. The primary long-term consideration is the successful development of immunological tolerance. In rare cases, prolonged immunotherapy has been associated with the development of Eosinophilic Esophagitis (EoE), particularly if the patient is being treated for food allergens, though this is more common with oral immunotherapy than subcutaneous injections.
While non-standardized extracts may not always carry a formal 'Black Box' in the same way as high-risk pharmaceuticals, the FDA requires all allergenic extracts to carry a prominent warning regarding Anaphylaxis. The warning states that these products can cause severe, life-threatening systemic reactions. They must only be administered by clinicians trained in the management of anaphylaxis and in facilities where emergency equipment is immediately available. Patients with unstable asthma are at a significantly increased risk for fatal outcomes.
Report any unusual symptoms to your healthcare provider.
Tangerine allergenic extract is a potent biological agent. The most critical safety consideration is the risk of a systemic allergic reaction. Patients must be informed that the 'safety' of a previous dose does not guarantee the safety of the next dose, as sensitivity can fluctuate based on factors like exercise, illness, or menstrual cycle.
No formal FDA black box warning exists for the specific 'Tangerine' label, but the entire class of Allergenic Extracts carries a class-wide warning for Anaphylaxis. This warning emphasizes that patients must be observed for at least 30 minutes post-injection and that the product is contraindicated in patients with severe or unstable asthma. Physicians must ensure patients have an unexpired epinephrine auto-injector and know how to use it.
No routine lab work (like CBC or LFTs) is required for tangerine extract. Instead, monitoring is clinical:
Most patients can drive after the 30-minute observation period. However, if a patient experiences significant fatigue or receives an antihistamine as part of their treatment, they should avoid operating heavy machinery until they know how they react.
Alcohol consumption should be avoided on the day of an injection or skin test. Alcohol causes vasodilation, which can potentially increase the rate of allergen absorption and exacerbate a systemic reaction.
Immunotherapy is typically discontinued if:
> Important: Discuss all your medical conditions with your healthcare provider before starting Tangerine.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Tangerine.
FDA Pregnancy Category C. There are no adequate and well-controlled studies of tangerine allergenic extract in pregnant women.
It is not known whether the allergenic proteins in tangerine extract are excreted in human milk. However, because these are large proteins that are likely digested in the infant's gut, the risk to a nursing infant is considered extremely low. The benefits of breastfeeding generally outweigh the theoretical risks of the mother receiving immunotherapy.
Tangerine extract is used in children as young as 2 years old for diagnostic purposes. For immunotherapy, it is rarely started in children under age 5 because of the difficulty in monitoring for systemic reactions and the child's inability to communicate early symptoms. Studies have shown that immunotherapy can be effective in children and may prevent the development of further allergies (the 'allergic march').
Patients over 65 are at a higher risk for complications from tangerine extract. This is primarily due to the higher prevalence of underlying coronary artery disease, hypertension, and the use of medications like beta-blockers or ACE inhibitors. In this population, the 'flare' from a skin test may also be less pronounced due to age-related changes in skin reactivity (atrophy of mast cells).
No specific studies have been conducted in patients with renal impairment. While the protein fragments are cleared renally, the doses used in immunotherapy are so small (micrograms of protein) that significant accumulation is unlikely. However, clinicians should monitor for any unusual systemic symptoms in patients with Stage 4 or 5 Chronic Kidney Disease.
Liver disease does not affect the safety or efficacy of tangerine allergenic extract, as the liver is not the primary site of action or metabolism for these allergenic proteins.
> Important: Special populations require individualized medical assessment.
Tangerine allergenic extract acts as a specific antigen that interacts with the adaptive immune system. In sensitized individuals, the extract's proteins (antigens) bind to the Fab portion of IgE antibodies. These IgE antibodies are 'sensitized' onto the high-affinity FcεRI receptors of mast cells and basophils. When the tangerine allergen cross-links two adjacent IgE molecules, it triggers an intracellular signaling cascade involving tyrosine kinases (like Syk), leading to the release of pre-formed mediators (histamine, heparin) and the de novo synthesis of leukotrienes.
In immunotherapy, the mechanism involves the induction of T-cell anergy and the expansion of CD4+ CD25+ Foxp3+ regulatory T-cells (Tregs). These Tregs produce IL-10 and TGF-beta, which suppress the allergic Th2 response and signal B-cells to switch production from IgE to IgG4.
| Parameter | Value |
|---|---|
| Bioavailability | Low (localized) for SPT; Variable for SCIT |
| Protein Binding | Minimal (binds to specific IgE/IgG) |
| Half-life | Minutes to hours (proteins); Days (immunological effect) |
| Tmax | 15-30 minutes (systemic absorption post-injection) |
| Metabolism | Proteolysis (enzymatic breakdown) |
| Excretion | Renal (as small peptide fragments) |
Tangerine extract is a Non-Standardized Allergenic Extract. It is grouped with other food and plant extracts like Orange, Lemon, and Lime extracts. It is distinct from 'Standardized' extracts like Short Ragweed or Dermatophagoides farinae (Dust Mite), which have federally mandated potency requirements.
Common questions about Tangerine
Tangerine allergenic extract is primarily used by medical specialists to diagnose and treat allergies to tangerines and related citrus fruits. In a diagnostic setting, a small amount of the extract is applied to the skin to see if it triggers an allergic 'wheal and flare' reaction. For treatment, it is used in allergen immunotherapy, where increasing doses are injected over time to help the immune system become less sensitive to the fruit. This is particularly helpful for patients who have severe reactions or who cannot easily avoid citrus exposure. It is not used for general nutrition or as a vitamin supplement.
The most common side effects of tangerine extract are localized reactions at the site of testing or injection. These include redness, itching, and a raised bump similar to a mosquito bite, which usually appears within minutes and fades within a few hours. Some patients may also experience larger areas of swelling or warmth on the arm after an immunotherapy injection. These local reactions are generally not dangerous but should be reported to your doctor. Systemic symptoms like sneezing or a runny nose can also occur but are less frequent than local skin changes.
It is strongly advised to avoid alcohol on the days you receive a tangerine extract injection or undergo skin testing. Alcohol can cause your blood vessels to dilate (expand), which may speed up the absorption of the allergen into your bloodstream and increase the risk of a severe systemic reaction. Additionally, alcohol can cause flushing or dizziness that might be confused with the early signs of anaphylaxis, making it harder for medical staff to monitor your safety. Always wait at least 24 hours after your treatment before consuming alcoholic beverages.
Tangerine extract is generally not started during pregnancy because of the risk that a severe allergic reaction (anaphylaxis) could harm both the mother and the developing baby by reducing oxygen flow. However, if a woman is already on a stable 'maintenance' dose of immunotherapy and is tolerating it well, many doctors will allow her to continue the treatment at that same dose. The dosage is usually not increased until after the baby is born. If you are pregnant or planning to become pregnant, you must discuss the risks and benefits of continuing or stopping allergy shots with your allergist.
For diagnostic purposes, tangerine extract works almost immediately, with results appearing on the skin within 15 to 20 minutes. However, when used as a treatment (immunotherapy), it takes much longer to see a clinical benefit. Most patients do not notice a significant reduction in their allergy symptoms until they have reached their 'maintenance dose,' which typically takes 3 to 6 months of weekly injections. Full effectiveness and long-term protection usually require a commitment to the treatment for 3 to 5 years. Patience and consistency are key to the success of this therapy.
Yes, you can stop receiving tangerine immunotherapy injections at any time without experiencing physical withdrawal symptoms like you might with other medications. However, stopping the treatment before the recommended 3-to-5-year course is finished means your allergy symptoms are likely to return, and you will lose the 'tolerance' your immune system has built up. If you miss several doses and then try to restart, you may be at a higher risk for a reaction, so your doctor will need to significantly lower your dose and start the build-up process over again.
If you miss a scheduled immunotherapy injection, you should contact your allergist's office as soon as possible to reschedule. Do not attempt to 'double up' on your next dose or take it at home. Depending on how many days or weeks have passed since your last injection, your doctor may need to reduce your next dose to ensure your safety. If too much time passes, your immune system's sensitivity may have increased, and a full dose could trigger a dangerous reaction. Your healthcare provider will determine the safest way to get you back on schedule.
There is no scientific evidence to suggest that tangerine allergenic extract causes weight gain. The extract consists of very small amounts of proteins and is administered in tiny volumes (usually less than 0.5 mL), which do not have enough calories or metabolic impact to affect body weight. If you notice significant weight changes while undergoing immunotherapy, it is likely due to other factors such as lifestyle changes, other medications (like oral steroids sometimes used for allergies), or an underlying medical condition. Always discuss weight concerns with your primary care physician.
Tangerine extract can interact with several types of medications, some of which are very serious. Most importantly, beta-blockers (used for heart conditions) can make it dangerous to receive allergy shots because they block the effects of emergency medicine like epinephrine. Antihistamines will interfere with skin testing by hiding the reaction, so they must be stopped several days before a test. Other drugs like ACE inhibitors or MAOIs may also increase the risk or severity of a reaction. Always provide your allergist with a complete and updated list of all medications you are taking.
Allergenic extracts like tangerine do not have 'generics' in the traditional sense that pills do. Instead, they are biological products manufactured by various specialized laboratories (such as Greer, ALK, or HollisterStier). While different companies may produce a 'Tangerine Extract,' they are not considered identical or interchangeable because they are non-standardized. Your doctor will typically stick with the same manufacturer's extract for your entire course of treatment to ensure the potency remains as consistent as possible, as switching brands could lead to an unexpected reaction.