Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Selenicereus Grandiflorus Stem, Crataegus Laevigata Fruit, And Spigelia Anthelmia
Brand Name
D-135
Generic Name
Selenicereus Grandiflorus Stem, Crataegus Laevigata Fruit, And Spigelia Anthelmia
Active Ingredient
Crataegus Laevigata FruitCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 2 [hp_X]/mL | SOLUTION | SUBLINGUAL | 58264-0141 |
Detailed information about D-135
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for D-135, you must consult a qualified healthcare professional.
Crataegus Laevigata Fruit, also known as Hawthorn, is classified as a Non-Standardized Food and Plant Allergenic Extract [EPC] used primarily in the diagnosis and treatment of specific hypersensitivity reactions.
Dosage for Crataegus Laevigata Fruit extract is highly individualized and must be determined by an allergist or immunologist based on the patient's sensitivity levels.
Crataegus Laevigata Fruit extracts can be used in children, but the dosage must be adjusted with extreme caution. Children may be more sensitive to allergens, and the risk of systemic reactions must be weighed carefully.
No specific dosage adjustments are required for renal impairment, as the systemic load of the extract is extremely low. However, patients with severe renal disease may be at higher risk if they require epinephrine to treat an allergic reaction.
No dosage adjustments are necessary for hepatic impairment.
Elderly patients (over 65) should be evaluated for underlying cardiovascular disease before starting immunotherapy. If an elderly patient is taking beta-blockers, immunotherapy may be contraindicated due to the difficulty in treating potential anaphylaxis.
If a dose of immunotherapy is missed, the next dose may need to be reduced depending on how much time has passed.
An overdose of an allergenic extract is defined as the administration of a dose that exceeds the patient's current tolerance level.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most patients receiving Crataegus Laevigata Fruit extract will experience some form of localized reaction. These are generally not dangerous but can be uncomfortable.
> Warning: Stop taking Crataegus Laevigata Fruit and call your doctor immediately if you experience any of these.
There are few documented long-term adverse effects of allergenic extracts when administered correctly. However, some patients may develop a persistent sensitivity to the extract, or in rare cases, 'serum sickness-like' reactions (joint pain, fever, and rash) if the immune system reacts excessively to the foreign proteins over many years.
No FDA black box warnings for Crataegus Laevigata Fruit. However, all allergenic extracts carry a general warning regarding the risk of severe systemic reactions, including anaphylaxis. The FDA requires that these extracts only be administered in settings where emergency treatment for anaphylaxis is immediately available.
Report any unusual symptoms to your healthcare provider.
Crataegus Laevigata Fruit extract is a potent biological substance that alters the immune system. It must never be self-administered. Patients must be aware that even if they have tolerated previous injections well, the risk of a systemic reaction is always present. Factors such as exercise, hot showers, or acute illness shortly after an injection can increase the rate of absorption and the risk of a reaction.
No FDA black box warnings for Crataegus Laevigata Fruit. While no specific box exists for this fruit extract, the class-wide warning for allergenic extracts emphasizes that they can cause severe, life-threatening systemic reactions. Patients with unstable asthma are at the highest risk for fatal outcomes during immunotherapy.
Generally, Crataegus Laevigata Fruit does not affect the ability to drive. However, if a patient experiences dizziness, fatigue, or a systemic reaction, they should not operate machinery until symptoms have fully resolved and they have been cleared by a medical professional.
There is no direct interaction between alcohol and the extract. However, alcohol consumption can cause vasodilation, which may theoretically increase the rate of allergen absorption and the severity of a potential allergic reaction. It is advisable to avoid alcohol for several hours after an injection.
Immunotherapy is typically a long-term commitment (3 to 5 years). Stopping the treatment prematurely may result in the return of allergy symptoms. There is no 'withdrawal syndrome,' but the immunological benefits will gradually fade if the maintenance phase is not completed.
> Important: Discuss all your medical conditions with your healthcare provider before starting Crataegus Laevigata Fruit.
For each major interaction, the mechanism involves either the masking of symptoms (pharmacodynamic) or the interference with emergency rescue medications (pharmacodynamic). The clinical consequence is usually an increased risk of untreated or severe anaphylaxis.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients should be aware of cross-sensitivity with other members of the Rosaceae family. This includes:
If a patient has had a severe reaction to any of these, they may be at a higher risk of reacting to Crataegus Laevigata Fruit extract.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Crataegus Laevigata Fruit.
Crataegus Laevigata Fruit extract is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. The primary risk during pregnancy is not the extract itself, but the potential for a systemic allergic reaction (anaphylaxis) in the mother. Anaphylaxis can cause a sudden drop in maternal blood pressure, leading to placental hypoperfusion and fetal hypoxia (lack of oxygen to the baby), which can result in fetal distress or death.
It is not known whether the allergenic components of Crataegus Laevigata Fruit are excreted in human milk. Because most allergens are large proteins that are digested in the infant's gut, the risk to a nursing infant is considered low. However, the decision to continue immunotherapy while breastfeeding should involve a risk-benefit analysis by the healthcare provider.
Immunotherapy with Crataegus Laevigata Fruit is generally considered safe for children ages 5 and older. The efficacy in children is well-documented for allergic rhinitis.
Patients over 65 years of age require a thorough cardiovascular evaluation before starting treatment. The elderly are more likely to have co-morbidities (like coronary artery disease or hypertension) and are more likely to be taking medications (like beta-blockers or ACE inhibitors) that increase the risk or severity of immunotherapy-related adverse events.
Specific studies in patients with renal impairment have not been conducted. However, because the dose of protein administered is minimal, no dosage adjustment is typically required. The main concern is the patient's ability to tolerate emergency medications if a reaction occurs.
No dosage adjustments are required for patients with liver disease, as the metabolism of the extract is handled by local and systemic proteases rather than hepatic CYP450 enzymes.
> Important: Special populations require individualized medical assessment.
Crataegus Laevigata Fruit extract contains a complex mixture of proteins, glycoproteins, and polysaccharides. In an allergic individual, these proteins act as antigens. When they enter the body, they are processed by Antigen-Presenting Cells (APCs), such as macrophages and dendritic cells. These APCs present the allergenic peptides to T-lymphocytes.
In sensitized individuals, this leads to the activation of Th2 cells, which secrete cytokines like IL-4 and IL-13, stimulating B-cells to produce IgE antibodies. The IgE then binds to high-affinity receptors (FcεRI) on mast cells. Upon re-exposure, the Crataegus allergens cross-link these IgE molecules, triggering the release of histamine and other mediators. Immunotherapy works by shifting this balance toward Th1 cells and Regulatory T-cells, leading to the production of 'blocking' IgG4 antibodies and IL-10, which suppress the allergic inflammation.
| Parameter | Value |
|---|---|
| Bioavailability | Low (Subcutaneous/Local) |
| Protein Binding | N/A (Biological Protein) |
| Half-life | Minutes to Hours (Proteolysis) |
| Tmax | 15-30 minutes (Local) |
| Metabolism | Tissue and Plasma Proteases |
| Excretion | Renal (as small peptides) |
Crataegus Laevigata Fruit belongs to the Non-Standardized Plant Allergenic Extract class. Related medications include extracts of other fruits (e.g., Apple, Strawberry) and pollens (e.g., Ragweed, Timothy Grass), though each is specific to the patient's unique sensitivity profile.
Common questions about D-135
In a clinical setting, Crataegus Laevigata Fruit extract is primarily used as a diagnostic tool to identify individuals with specific allergies and as a treatment in allergen immunotherapy. During diagnostic testing, a small amount is applied to the skin to check for an allergic reaction. For treatment, it is used in 'allergy shots' to help the body build up a tolerance to the fruit's allergens over time. This can significantly reduce symptoms for patients who experience allergic rhinitis or asthma triggered by this plant. It is also sometimes used off-label in herbal medicine for cardiovascular support, though this is a different preparation than the allergenic extract.
The most common side effects are localized to the site where the extract was applied or injected. Patients frequently experience redness, swelling, and itching at the injection site, often referred to as a 'wheal and flare' reaction. These symptoms usually appear within minutes and typically resolve on their own within a few hours. Some patients may also experience a 'large local reaction,' where the swelling extends several inches across the arm. While uncomfortable, these local reactions are generally not dangerous and can be managed with cold compresses or over-the-counter antihistamines as directed by a doctor.
It is generally recommended to avoid alcohol for several hours before and after receiving an injection of Crataegus Laevigata Fruit extract. Alcohol causes vasodilation, which is the widening of blood vessels, and this can potentially speed up the absorption of the allergen into your bloodstream. This increased absorption rate may rise the risk of a systemic allergic reaction or make a reaction more severe if it occurs. Additionally, alcohol can sometimes mask the early symptoms of an allergic reaction, such as dizziness or flushing. Always consult your healthcare provider about your lifestyle habits during immunotherapy.
The use of Crataegus Laevigata Fruit extract during pregnancy is handled with extreme caution. It is classified as Pregnancy Category C, meaning there is not enough data to guarantee its safety for the fetus. The main concern is not the extract itself, but the risk of the mother having a severe allergic reaction (anaphylaxis), which could deprive the baby of oxygen. Most allergists will not start a new course of immunotherapy during pregnancy. However, if a patient is already on a stable maintenance dose and tolerating it well, the doctor may decide to continue the treatment, as the risk of a reaction is much lower at that stage.
The timeframe for seeing results from Crataegus Laevigata Fruit immunotherapy is relatively long. While diagnostic skin tests work within 20 minutes, the therapeutic 'desensitization' process is gradual. Most patients begin to notice a reduction in their allergy symptoms during the 'maintenance phase,' which usually starts 3 to 6 months after the beginning of treatment. Significant and long-lasting improvement typically requires a consistent treatment plan lasting 3 to 5 years. It is important to remain patient and follow the injection schedule strictly to achieve the best immunological results.
Yes, you can stop taking Crataegus Laevigata Fruit extract suddenly without experiencing physical withdrawal symptoms, as it is not an addictive substance. However, stopping the treatment before the recommended 3-to-5-year course is complete will likely result in the return of your allergy symptoms over time. The immune system requires long-term exposure to the extract to maintain the 'tolerance' it has built up. If you need to stop treatment due to side effects or life changes, you should discuss a tapering or discontinuation plan with your allergist to understand how it will affect your allergy management.
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. Because the treatment relies on a precise build-up of allergen tolerance, missing a dose may mean your next dose needs to be lowered to ensure safety. If only a few days have passed, you might receive your usual dose, but if several weeks have passed, your doctor will likely need to reduce the concentration of the extract to prevent an allergic reaction. Consistency is the key to successful and safe immunotherapy.
There is no clinical evidence to suggest that Crataegus Laevigata Fruit extract, when used as an allergenic extract for testing or immunotherapy, causes weight gain. The amount of the substance administered is extremely small and does not have metabolic effects that would lead to an increase in body fat or water retention. If you notice weight changes while on this treatment, it is likely due to other factors, such as lifestyle changes or other medications (like oral corticosteroids) you may be taking for your allergies. Always discuss unexpected weight changes with your primary care physician.
Crataegus Laevigata Fruit extract can interact with several types of medications, some of which are very serious. The most critical interaction is with beta-blockers, which are often used for heart conditions or high blood pressure; these can make it very difficult to treat a severe allergic reaction if one occurs. Other medications like ACE inhibitors, MAOIs, and tricyclic antidepressants can also increase the risks associated with immunotherapy. Antihistamines may be taken but can sometimes hide the early warning signs of a reaction. You must provide your allergist with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you are using.
Crataegus Laevigata Fruit extract is a biological product, and the concept of 'generic' versions works differently than it does for standard chemical pills. Various manufacturers, such as GREER, ALK-Abello, and HollisterStier, produce their own versions of this non-standardized extract. While they all contain the same basic fruit allergens, they are not necessarily interchangeable because their potencies (measured in w/v or PNU) may differ slightly based on the manufacturer's specific extraction process. Your allergist will typically stick with one manufacturer's product for the duration of your treatment to ensure the dosage remains consistent and safe.
Other drugs with the same active ingredient (Crataegus Laevigata Fruit)