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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Apis Mellifica
Brand Name
Apis Mellifica
Generic Name
Apis Mellifica
Active Ingredient
Apis MelliferaCategory
Standardized Insect Venom Allergenic Extract [EPC]
Variants
11
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 100 [hp_C]/1 | PELLET | ORAL | 63545-052 |
| 1 [hp_M]/1 | PELLET | ORAL | 63545-055 |
| 1 [hp_X]/1 | PELLET | ORAL | 15631-0039 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Apis Mellifica, you must consult a qualified healthcare professional.
| 12 [hp_C]/1 | PELLET | ORAL | 63545-050 |
| 6 [hp_C]/6[hp_C] | PELLET | ORAL | 66096-786 |
| 200 [hp_C]/1 | PELLET | ORAL | 63545-053 |
| 6 [hp_C]/1 | PELLET | ORAL | 63545-049 |
| 30 [hp_C]/1 | PELLET | ORAL | 63545-051 |
| 1 [hp_Q]/1 | PELLET | ORAL | 63545-057 |
| 500 [hp_C]/1 | PELLET | ORAL | 63545-054 |
| 10 [hp_M]/1 | PELLET | ORAL | 63545-056 |
Detailed information about Apis Mellifica
Apis Mellifera is a standardized insect venom allergenic extract used primarily for the diagnosis and treatment of honey bee venom hypersensitivity. It is a critical component of venom immunotherapy (VIT) to prevent life-threatening anaphylactic reactions.
Apis Mellifera is approved for use in children. The dosing schedule for pediatric patients is generally identical to the adult schedule, as the goal is to achieve a protective level of IgG antibodies regardless of body weight.
No specific dose adjustments are typically required for renal impairment, though patients should be monitored for systemic reactions.
No specific dose adjustments are required for hepatic impairment.
Elderly patients may be at higher risk for complications if a systemic reaction occurs (e.g., due to pre-existing cardiovascular disease). Healthcare providers may adjust the rate of dose escalation.
Apis Mellifera must be administered by a healthcare professional in a clinical setting equipped to treat anaphylaxis.
If a dose is missed during the induction phase, the healthcare provider may need to repeat the previous dose or even reduce the dose depending on the length of the delay. During maintenance, a delay of more than 2-3 weeks may require a temporary dose reduction to ensure safety.
An overdose of Apis Mellifera (either a dose given too quickly or a higher-than-intended concentration) can lead to severe systemic reactions or anaphylaxis.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Apis Mellifera is a potent biological extract. It is intended only for patients with a clear clinical history of honey bee allergy and a positive skin or blood test. It should never be self-administered.
According to the FDA-approved labeling, Apis Mellifera carries a boxed warning regarding the risk of severe systemic allergic reactions. Anaphylaxis may occur within minutes of administration. Emergency equipment, including epinephrine and airway management tools, must be immediately available.
FDA Pregnancy Category C. Venom immunotherapy is generally not initiated during pregnancy due to the risk of maternal anaphylaxis, which can cause fetal hypoxia. However, if a patient is already on a stable maintenance dose and becomes pregnant, the treatment is usually continued as the risk of a reaction from a natural sting is considered greater than the risk of maintenance injections.
It is not known whether the components of Apis Mellifera pass into breast milk. However, since the proteins are digested in the infant's gut, the risk to the nursing infant is considered negligible. Maintenance therapy is generally considered safe during breastfeeding.
Apis Mellifera is approved for children. Studies have shown that VIT is highly effective in the pediatric population, often providing long-lasting protection even after the treatment is discontinued.
Apis Mellifera extract works by inducing immunological tolerance. It stimulates the production of T-regulatory cells, which secrete IL-10 and TGF-beta. These cytokines suppress the allergic Th2 response and promote the class-switching of B-cells to produce IgG4. This "blocking antibody" prevents the allergen from binding to IgE on mast cells, effectively raising the threshold for an allergic reaction.
The primary pharmacodynamic effect is the reduction of skin reactivity and systemic sensitivity to honey bee venom. The onset of protection begins during the build-up phase, but full protection is typically achieved only after reaching the maintenance dose of 100 mcg. The duration of effect can last for years after a 5-year course of treatment.
| Parameter | Value |
|---|---|
Common questions about Apis Mellifica
Apis Mellifera is primarily used for Venom Immunotherapy (VIT) to treat individuals with a history of severe allergic reactions to honey bee stings. By administering small, increasing amounts of the venom, healthcare providers can help the patient's immune system build up a tolerance. This significantly reduces the risk of life-threatening anaphylaxis if the person is stung again in the future. It is also used as a diagnostic tool in skin testing to confirm a honey bee venom allergy. This treatment is essential for those whose occupations or lifestyles put them at high risk for bee stings.
The most common side effects are localized to the site of the injection and include redness, swelling, and itching. These reactions are typically mild and resolve within a day or two. Some patients may experience a 'large local reaction,' where the swelling extends several inches from the injection site. Systemic side effects like fatigue or a mild headache can also occur shortly after treatment. Because it is an allergen, there is always a small risk of a more serious reaction, which is why it must be given in a doctor's office.
It is strongly advised to avoid alcohol on the day of your Apis Mellifera injection. Alcohol causes vasodilation (widening of the blood vessels), which can increase the speed at which the venom extract is absorbed into your bloodstream. This rapid absorption can increase the likelihood of a systemic allergic reaction or anaphylaxis. Furthermore, alcohol can mask the early symptoms of an allergic reaction, making it harder for you or your doctor to recognize an emergency. Always wait at least 24 hours after your injection before consuming alcoholic beverages.
Apis Mellifera is generally not started during pregnancy because the risk of a severe allergic reaction during the 'build-up' phase could harm the fetus by reducing oxygen supply. However, if a woman is already on a stable maintenance dose and becomes pregnant, most allergists recommend continuing the treatment. This is because the risk of a reaction from a natural bee sting is often considered more dangerous than the controlled maintenance injections. Decisions regarding VIT during pregnancy are made on a case-by-case basis by a specialist. Always inform your healthcare provider if you are pregnant or planning to become pregnant.
Protection from honey bee stings does not happen immediately; it develops gradually as you move through the induction or 'build-up' phase. Most patients reach a protective level of immunity once they hit their maintenance dose, which typically takes 3 to 6 months of weekly injections. Once the maintenance level is reached, the injections are spaced out to every 4 to 8 weeks. Clinical studies show that about 95% of patients are protected from systemic reactions once they are on a stable maintenance dose. Your doctor will determine the exact timeline based on your specific sensitivity levels.
While you can stop the treatment at any time, doing so before completing the recommended course (usually 3 to 5 years) will likely result in the loss of your immunity. If you stop suddenly, your risk of having a severe allergic reaction to a future bee sting may return to its original level. It is important to discuss your desire to stop with your allergist so they can evaluate your current level of protection. In some cases, a blood test (IgE/IgG levels) can help determine if it is safe to discontinue. Never stop your immunotherapy schedule without consulting your medical team first.
If you miss a dose of Apis Mellifera, you should contact your allergist immediately to reschedule. The safety of the next injection depends on how much time has passed since your last dose. If only a few days have passed, your doctor may give you the scheduled dose; however, if several weeks have passed, they may need to reduce the dose to prevent a reaction. Missing multiple doses may require you to restart a portion of the build-up phase. Consistency is key to both the safety and effectiveness of venom immunotherapy.
There is no clinical evidence to suggest that Apis Mellifera or other venom allergenic extracts cause weight gain. The treatment consists of very small amounts of proteins and enzymes that interact with the immune system locally and do not affect metabolic rate or appetite. If you experience weight changes while on this treatment, it is likely due to other factors or medications. Always discuss unexpected weight changes with your primary care physician. Apis Mellifera is not associated with the hormonal changes that typically lead to drug-induced weight gain.
Apis Mellifera can interact with several important medications, most notably beta-blockers used for heart conditions or high blood pressure. Beta-blockers can make an allergic reaction harder to treat because they interfere with epinephrine. ACE inhibitors, another type of blood pressure medication, may also increase the risk of a severe reaction. You should also inform your doctor if you are taking MAO inhibitors or tricyclic antidepressants. It is vital to provide a complete list of all medications, including over-the-counter drugs and supplements, to your allergist before starting treatment.
Apis Mellifera is a biological product, so it is not available as a 'generic' in the same way simple chemical drugs are. Instead, it is available under various brand names and as standardized extracts from different manufacturers, such as HollisterStier or ALK-Abelló. These products are all standardized to contain specific amounts of the major allergen, Phospholipase A2. While different brands may be used, they are generally considered therapeutically equivalent for the purposes of venom immunotherapy. Your clinic will typically use a consistent source for your entire course of treatment.
Other drugs with the same active ingredient (Apis Mellifera)
> Warning: Stop taking Apis Mellifera and call your doctor immediately if you experience any of these.
Long-term use in immunotherapy is generally well-tolerated. Some patients may develop persistent nodules at the injection site, though this is rare with standardized extracts.
Apis Mellifera can cause severe, life-threatening systemic allergic reactions, including anaphylaxis. This medication should only be administered by healthcare professionals experienced in the treatment of life-threatening allergic reactions. Patients must be observed for at least 30 minutes after administration. This product may not be suitable for patients with severe or unstable asthma or those taking certain medications like beta-blockers.
Report any unusual symptoms to your healthcare provider.
Apis Mellifera generally does not affect the ability to drive. However, if a patient experiences dizziness or a vasovagal reaction after the injection, they should wait until symptoms resolve before operating machinery.
Alcohol consumption should be avoided on the day of the injection, as alcohol can increase blood flow to the skin and potentially accelerate the absorption of the allergen, increasing the risk of a reaction.
Immunotherapy is typically continued for 3 to 5 years. Stopping treatment prematurely may result in a loss of the protective effect, leaving the patient at risk for anaphylaxis from future bee stings.
> Important: Discuss all your medical conditions with your healthcare provider before starting Apis Mellifera.
Apis Mellifera administration will lead to an increase in venom-specific IgG antibodies and a transient increase in venom-specific IgE. This is an expected pharmacological effect and not a "false" result.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
There is some cross-reactivity between honey bee venom and other Hymenoptera (like bumblebee venom), but there is minimal cross-reactivity with Vespids (yellow jackets, hornets, wasps). Testing is required for each specific venom.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Apis Mellifera.
Patients over 65 may have a higher prevalence of cardiovascular disease, making them more vulnerable to the side effects of epinephrine. Dose escalation may be performed more conservatively.
No specific GFR-based adjustments are documented, as the drug is a biological protein extract primarily processed by the immune system and local proteases.
No adjustments are required for patients with liver disease.
> Important: Special populations require individualized medical assessment.
| Protein Binding | Variable (Immune Complex Formation) |
| Half-life | Minutes (Peptides) to Hours (Enzymes) |
| Tmax | 1-2 hours (Systemic absorption of components) |
| Metabolism | Proteolysis by endogenous enzymes |
| Excretion | Renal (Small peptide fragments) |
Apis Mellifera extract is a mixture of proteins, peptides, and biogenic amines. The primary allergen is Phospholipase A2 (MW ~14,500 Da). Other major components include Melittin (a 26-amino acid peptide) and Hyaluronidase. The extract is soluble in aqueous diluents containing human serum albumin and phenol.
Apis Mellifera is a Standardized Insect Venom Allergenic Extract. It is related to other venom extracts such as Vespula species (Yellow Jacket) and Polistes species (Wasp) extracts.