FDA approves Evolocumab (Repatha) to treat high cholesterol:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

©   On 27^th Aug 2015, the U.S. Food and Drug Administration approved Evolocumab (Repatha) injection to treat high cholesterol.

©   Evolocumab is the second PCSK9 (Proprotein Convertase Subtilisin Kexin type9) inhibitor.

©   Evolocumab (Repatha) is approved to treat adult patients with…

Ø Heterozygous familial hypercholesterolemia (HeFH)

Ø Homozygous familial hypercholesterolemia (HoFH)

Ø Who require additional lowering of LDL cholesterol (i.e Whose cholesterol is not controlled by diet and Statin treatment)

©    The recommended dose of Evolocumab for adults, is 140 mg every two weeks or 420 mg once a month.

Mechanism of Action:

©   Evolocumab (Repatha) binds to a protein called Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) and inhibits its binding to low density lipoprotein receptors (LDLR) at the surface of hepatocytes. When PCSK9 binds to cell surface LDLR, lysosomal degradation of LDLR occurs. But, inhibition of PCSK9 binding to LDLR by Evolocumab prevents the lysosomal degradation and increases the number of LDLR available to clear LDL particles leading to lowering of LDL cholesterol.

Adverse Drug Reactions:

©  The most common ADRs noted in the clinical trial participants being treated with Evolocumab, include Nasopharyngitis, Upper respiratory tract infection, Flu like symptoms, Back pain, Redness, pain, or bruising  at the injection site and Allergic reactions (Rash and hives).

FDA approves Flibanserin (Addyi) to treat Hypoactive Sexual Desire Disorder (HSDD):

 

More Presentations from Dr.Naina Mohamed Pakkir Maideen

Ø On 18^th Aug 2015, The U.S. Food and Drug Administration approved Flibanserin (Addyi) to treat acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Ø Flibanserin (Addyi) is the first FDA-approved treatments for sexual desire disorders in men or women.

Proposed Mechanism of Action:

Ø Flibanserin activates 5-HT_1A receptors in the prefrontal cortex and improves the balance between excitatory (Dopamine and Norepinephrine) & inhibitory (Serotonin) neurotransmitter systems, at prefrontal cortex leading to regulation of sexual response.

Adverse Drug Reactions:

Ø The most common ADRs noted in the clinical trial participants being treated with Flibanserin, include Dizziness, Somnolence (Sleepiness), Nausea, Fatigue, Insomnia and Dry mouth.

Drug Interactions:

Ø Flibanserin can interact significantly with Alcohol, CYP3A4 Inhibitors, CYP3A4 Inducers, CYP2C19 Inhibitors, Digoxin or other P-gp Substrates and Other CNS Depressants.

Contraindications:

Ø Alcohol consumption

Ø Concomitant use of CYP3A4 Inhbitors such as Macrolide Antibiotics (Erythromycin, Clarithromycin, Telithromycin, etc.), Azole Antifungals (Ketoconazole, Fluconazole, Itraconazole, etc.), Antiretroviral protease inhibitors (Saquinavir, Ritonavir, Indinavir, Nelfinavir, Amprenavir, etc.), Ciprofloxacin, Verapamil, Grapefruit juice, etc.

Ø Hepatic Impairment

                             

FDA approves Alirocumab (Praluent) to treat high cholesterol:

More Presentations from Naina Mohamed Pakkir Maideen

©  On 24^th July 2015, the U.S. Food and Drug Administration approved Alirocumab (Praluent) injection to treat high cholesterol.

©   Alirocumab is the first PCSK9 (Proprotein Convertase Subtilisin Kexin type9) inhibitor.

©   Alirocumab(Praluent) is approved to treat adult patients …

Ø With Heterozygous familial hypercholesterolemia (HeFH)

Ø Who require additional lowering of LDL cholesterol (i.e Whose cholesterol is not controlled by diet and Statin treatment)

©    The usual starting dose of Alirocumab is 75 mg/2 weeks.

Mechanism of Action:

©   Alirocumab (Praluent) binds to a protein called Proprotein Convertase Subtilisin Kexin type 9 (PCSK9) and inhibits its binding to low density lipoprotein receptors (LDLR) at the surface of hepatocytes. When PCSK9 binds to cell surface LDLR, lysosomal degradation of LDLR occurs. But, inhibition of PCSK9 binding to LDLR by Alirocumab prevents the lysosomal degradation and increases the number of LDLR available to clear LDL particles leading to lowering of LDL cholesterol.

Adverse Drug Reactions:

©  The most common ADRs noted in the clinical trial participants being treated with Alirocumab, include Nasopharyngitis, Itching, swelling, pain, or bruising at injection site, Flu like symptoms, Urinary tract infection, Diarrhea, Bronchitis, Myalgia, Muscle spasms, Sinusitis, Cough and Allergic reactions.

FDA approves Entresto (A new Heart Failure Drug):

More Presentations from Naina Mohamed Pakkir Maideen

©  On 07^th July 2015, the U.S. Food and Drug Administration approved Entresto tablets for the treatment of heart failure.

©  Entresto is a crystalline complex composed of 2 molecular moieties…

Ø Sacubitril (Neprilysin inhibitor )

Ø Valsartan (Angiotensin Receptor Blocker)     

Mechanism of Action:

©  Sacubitril blocks the degradation of endogenous vasoactive peptides (ANP, BNP, bradykinin, and Adrenomedullin), by inhibiting Neprilysin enzyme.

©  Valsartan decreases vasoconstriction and sodium retention by blocking the binding of Angiotensin II to the AT 1 receptors (Vascular smooth muscle and the adrenal gland).

Adverse Drug Reactions:

©  The most common ADRs noted in the clinical trial participants being treated with Entresto include Hypotension, Hyperkalemia, Cough, Dizziness and Renal Impairment.

Contraindications:

©  Entresto is contraindicated in patients taking Aliskiren and ACEIs and in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy.

Drug Interactions:

©  Entresto may interact significantly with drugs such asACE Inhibitors, Aliskiren, ARB, Potassium-sparing diuretics, NSAIDsandLithium.

Pregnancy:

©  Use of Entresto should be discontinued as soon as possible, if pregnancy is detected.

Lactation:

©  Use of Entresto or Breastfeeding should be discontinued.

FDA approves Cangrelor (A new Antiplatelet drug):

More presentations from Naina Mohamed Pakkir Maideen

©  On 22.06.15, The U.S. Food and Drug Administration approved Cangrelor (Kengreal) which is a new intravenous antiplatelet drug could be used with Percutaneous coronary intervention (PCI) for the treatment of stable angina or acute coronary syndromes (ACS, or myocardial infarction (MI) and unstable angina (UA)).

©  Cangrelor (Kengreal) is an intravenous (IV), direct acting, reversible competitive inhibitor of P2Y12 receptor.

Mechanism of Action:

©  Cangrelor blocks P2Y12 receptors of Platelet cell membranes causing inhibition of release of ADP and other mediators such as TxA2 and inhibition of activation of Glycoprotein IIb/IIIa which result in to the inhibition of Platelet activation and aggregation.

Adverse Drug Reactions:

©  The ADRs such as Dyspnea, Vomiting, Nausea, Headache and Hypotension have been noted with Cangrelor use.

Contraindications:

Cangrelor is contraindicated in patients with significant active bleeding and patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor.

Pharmacogenetics:

More Presentations from Dr.Naina Mohamed Pakkir Maideen

*      Pharmacogenetics is the study of influences of a gene on therapeutic and adverse effects of drugs.

*       Primaquine induced hemolysis in patients with G6PD (Glucose-6-Phosphate Dehydrogenase ) deficiency, was the first pharmacogenetic discovery.

*      The term Pharmacogenetics was coined by Vogel in 1959.

*      Two main divisions of Pharmacogenetics include…

Ø Drug-disposition Pharmacogenetics

Ø Drug-target Pharmacogenetics

*      Drug-Disposition Pharmacogenetics deals with the pharmacokinetics of a drug.

*      Drug-Target Pharmacogenetics deals with the pharmacodynamics of a drug.

*      Pharmacogenetic Studies include…

Ø Candidate-gene studies

Ø Genome-wide association study (GWAS)

*      The Candidate-gene approach, tests how frequent an allele or a set of alleles in patients who have a better (or worse) drug response.

*      The role of common genetic variations in disease or drug response surveyed by Genome-Wide Association Study (GWAS).

*      Pharmacists can take a lead in application of pharmacogenetics in clinical practice, since they are experts in pharmacokinetics and pharmacodynamics.

*      Health-care providers will increasingly need to take pharmacogenetics into consideration when prescribing medications.

TIPS for Healthy Hajj

More from Naina Mohamed, PhD

General Health TIPS for Hajj Pilgrims:

§    Maintain personal hygiene

§    Take bath regularly

§    Wash hands with soap and water

§    Cover nose and mouth while sneezing

§    Use always a face-mask

§    Change face face-mask every 6 hourly

§    Eliminate waste in trash only

§    Avoid spitting on floor

TIPS for Hajj Pilgrims with Chronic diseases:

§    Assess the health condition with a doctor before setting out for Hajj

§    Take sufficient medications

§    Keep medications in a proper storage conditions

§    Take medicines on time

§    Follow doctors’ and pharmacists’ instructions

§    Put on a wrist strap containing information such as name, age, disease, treatment, address and contact details

§    Inform fellow pilgrims about your disease and medications

§    Avoid making too much effort

§    Head to the nearest health center, if needed

Shaving and Hair-cutting TIPS for Hajj Pilgrims:

§    Never choose street barbers

§    Insist on using disposable shavers

§    Never share hair brush, sponges, etc. with others

§    Ask the barber to wash his hands before shaving or hair-cutting

TIPS to avoid Heat Exhaustion and Sunstrokes during Hajj:

§    Drink enough liquids (Water, Juices, Soups, etc.)

§    Avoid longer exposure to the sun

§    Use an umbrella

§    Avoid making excessive effort

§    Take sufficient rest after making every hajj ritual

§    Wear light and loose clothes

§    The signs and symptoms of heat exhaustion and sunstrokes include high body temperature, headache,  dizziness, nausea, fatigue, thirst and muscle cramps

TIPS to get protection from Food poisoning during Hajj:

§    Wash fruits and vegetables before eating

§    Check the expiry of canned foods and drinks before buying

§    Never buy uncovered food

§    Wash hands before and after preparing food

§    Wash hands before and after eating

§    Eat foods immediately after cooking

§    Avoid storing foods in buses for long

TIPS to avoid Nausea and Vomiting during Hajj:

§    Do not eat and drink too much

§    Avoid fatty foods

§    Drink enough fluids to avoid dehydration

§     Consult the doctor if vomiting is severe and persisting

TIPS to prevent Diarrhea during Hajj:

§    Avoid fatty foods

§    Check the cleanliness of foods

§    Cook the food properly

§    Do not buy from street vendors

§    Wash hands every now and then

§    Drink much liquid to avoid dehydration

§    Visit the nearest health center if diarrhea persists

TIPS to prevent Constipation during Hajj:

§    Drink enough liquid

§    Avoid cheese and dairy products

§    Eat more fresh fruits and vegetables

§    Eat more prunes which have lots of fiber

§    Avoid caffeinated drinks

§    Consume bulky agents such as fenugreek, flaxseed

TIPS to prevent Dermatological diseases during Hajj:

§    Maintain personal hygiene

§    Take bath regularly

§    Use powder and moisturizing cream when needed

§    Walk using long steps to avoid exfoliation

§    Keep thigh area clean and dry

TIPS to prevent Respiratory diseases during Hajj:

§    Use always a face-mask

§    Change face face-mask every 6 hourly

§    Cover nose and mouth while sneezing or coughing

§    Do not drink ice cold water

§    Keep away from the A/C while sweating

TIPS to prevent Tuberculosis (TB) during Hajj:

§    Use always a face-mask

§    Change face face-mask every 6 hourly

§    Avoid overcrowded places

§    Cover nose and mouth while sneezing or coughing

§    Wash hands every now and then

§    Keep residences well ventilated

§    Inform the Hajj mission doctor, if a fellow hajj coughing all the time

TIPS to prevent Xerophthalmia (Dryness of Eyes) during Hajj:

§    Use sunglasses

§    Consult with oculist before using contact lenses

§    Use moisturizing eye drops after consulting with oculist

General TIPS to perform Hajj:

§    Do not ignite fire inside the tents

§    Do not sleep on the pavements and roadsides

§    Do not get on top of buses or vehicles

§    Do not bump on others

§    Visit nearest health facility if required

§    Follow the directions issued by authorities

§    Do not slaughter the sacrifice on roads

Use the designated toilets only